[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06163534":3,"trial-entities:NCT06163534":585,"trial-summary:NCT06163534":589},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":30,"primary_purpose":17,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":36,"secondary_outcomes":41,"sex":48,"minimum_age":49,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":50,"std_ages":64,"locations":67,"central_contacts":486,"overall_officials":491,"references":496,"see_also_links":584},"NCT06163534","TP-CA-006","A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)","TEMPUS PHOENIX HNSCC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)","RECRUITING","2028-03-01","2026-06","2026-06-12","2024-08-01","Tempus AI","INDUSTRY",false,"The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.",null,[19],"Head and Neck Squamous Cell Carcinoma",[21,22,23,24,25,26,27,28,29],"Oncology","Biomarkers","Genomic Profiling","HNSCC","Cancer","Observational","Registry","Precision Medicine","NGS","OBSERVATIONAL",[],{"count":33,"type":34},500,"ESTIMATED",[],[37],{"measure":38,"description":39,"timeFrame":40},"Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.","Use NGS, ctNDA assessments, RNA analysis, and other multiomic testing to uncover biomarkers of collected blood and tissue samples that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.","5 years",[42,45],{"measure":43,"description":44,"timeFrame":40},"Explore changes in relevant DNA, RNA, immune and multiomic biomarkers in longitudinal blood samples, and diagnostic and progression biopsy samples, to understand real-world outcomes and resistance mechanisms.","Correlate biomarkers of collected blood and tissue samples with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.",{"measure":46,"description":47,"timeFrame":40},"Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker.","Assess changes in ctNDA of collected blood samples using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, duration, time to ctDNA recurrence with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation.","ALL","18 Years",{"inclusion":51,"exclusion":57,"raw_text":63},[52,53,54,55,56],"≥18 years of age","Willing and able to provide informed consent","Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies","Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy","Must submit tumor tissue sample representative of current disease per laboratory manual",[58,59,60,61,62],"Non-squamous histologies (eg, nasopharynx or salivary gland)","Relapse or recurrence within 6 months of first line chemotherapy and \u002F or chemoradiotherapy","Tumors that are PD-L1 negative (CPS \\\u003C1)","Clinical evidence of an active second invasive malignancy within \\\u003C2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers","Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)","Inclusion Criteria:\n\n* ≥18 years of age\n* Willing and able to provide informed consent\n* Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies\n* Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy\n* Must submit tumor tissue sample representative of current disease per laboratory manual\n\nExclusion Criteria:\n\n* Non-squamous histologies (eg, nasopharynx or salivary gland)\n* Relapse or recurrence within 6 months of first line chemotherapy and \u002F or chemoradiotherapy\n* Tumors that are PD-L1 negative (CPS \\\u003C1)\n* Clinical evidence of an active second invasive malignancy within \\\u003C2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers\n* Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)",[65,66],"ADULT","OLDER_ADULT",[68,86,99,110,124,139,154,165,176,191,205,219,234,249,264,275,288,303,317,331,346,361,375,389,404,417,432,447,462,477],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":83},"City of Hope","Duarte","California","91010","United States",[75,80],{"name":76,"role":77,"phone":78,"email":79},"Angelica Hamilton","CONTACT","626-218-0109","ahamilton@coh.org",{"name":81,"role":82},"Ravi Salgia","PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},34.13945,-117.97729,{"facility":87,"status":8,"city":88,"state":71,"zip":89,"country":73,"contacts":90,"geoPoint":96},"USC\u002FNorris Comprehensive Cancer Center","Los Angeles","90033",[91,94],{"name":92,"role":77,"email":93},"Sandy Tran","sandy.tran@med.usc.edu",{"name":95,"role":82},"Jacob 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University","30322",[169,173],{"name":170,"role":77,"phone":171,"email":172},"Johana Cruz","404-686-3925","johana.cruz@emory.edu",{"name":174,"role":82},"Nabil Saba, MD",{"lat":152,"lon":153},{"facility":177,"status":8,"city":178,"state":179,"zip":180,"country":73,"contacts":181,"geoPoint":188},"Northwestern University Feinberg School of Medicine","Chicago","Illinois","60611",[182,186],{"name":183,"role":77,"phone":184,"email":185},"Genesis Chase","312-695-1519","genesis.chase@northwestern.edu",{"name":187,"role":82},"Jochen Lorch",{"lat":189,"lon":190},41.85003,-87.65005,{"facility":192,"status":8,"city":193,"state":179,"zip":194,"country":73,"contacts":195,"geoPoint":202},"Cancer Care Specialists of Illinois","Decatur","62526",[196,200],{"name":197,"role":77,"phone":198,"email":199},"Kaitlynn Kapp","618-589-9721","kkapp@ccsci.net",{"name":201,"role":82},"James Wade",{"lat":203,"lon":204},39.84031,-88.9548,{"facility":206,"status":8,"city":207,"state":179,"zip":208,"country":73,"contacts":209,"geoPoint":216},"Illinois Cancer Care","Peoria","61615",[210,214],{"name":211,"role":77,"phone":212,"email":213},"Emilie Nkangu","309-243-3663","enkangu@illinoiscancercare.com",{"name":215,"role":82},"Fahad Asad",{"lat":217,"lon":218},40.69365,-89.58899,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":73,"contacts":224,"geoPoint":231},"University of Kansas","Westwood","Kansas","66205",[225,229],{"name":226,"role":77,"phone":227,"email":228},"Emmanuel Mado","913-945-9429","emadu@kumc.edu",{"name":230,"role":82},"Prakash Neupane",{"lat":232,"lon":233},39.04056,-94.6169,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":73,"contacts":239,"geoPoint":246},"University of Maryland","Baltimore","Maryland","21202",[240,244],{"name":241,"role":77,"phone":242,"email":243},"Rehan Khan","410-328-7496","Rehan.Khan@umm.edu",{"name":245,"role":82},"Ranee Mehra",{"lat":247,"lon":248},39.29038,-76.61219,{"facility":250,"status":8,"city":251,"state":252,"zip":253,"country":73,"contacts":254,"geoPoint":261},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",[255,259],{"name":256,"role":77,"phone":257,"email":258},"Sage Yenari","617-632-8039","sage_yenari@dfci.harvard.edu",{"name":260,"role":82},"Robert Haddad",{"lat":262,"lon":263},42.35843,-71.05977,{"facility":265,"status":8,"city":266,"state":267,"zip":268,"country":73,"contacts":269},"Henry Ford","Detriot","Michigan","48202",[270,273],{"name":271,"role":77,"email":272},"Molly Constantino","mcostan3@hfhs.org",{"name":274,"role":82},"Matthew Wilkins",{"facility":276,"status":8,"city":277,"state":267,"zip":278,"country":73,"contacts":279,"geoPoint":285},"Karmanos Cancer Institute","Detroit","48201",[280,283],{"name":281,"role":77,"email":282},"Walid Sukari","sukkarim@karmanos.org",{"name":284,"role":82},"Ammar Sukari, MD",{"lat":286,"lon":287},42.33143,-83.04575,{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":73,"contacts":293,"geoPoint":300},"Oncology Hematology Associates","Springfield","Missouri","65807",[294,298],{"name":295,"role":77,"phone":296,"email":297},"Adrianna Moore","417-882-4880","adrianna.moore@aoncology.com",{"name":299,"role":82},"V. Roger Holden, MD, PHD",{"lat":301,"lon":302},37.21533,-93.29824,{"facility":304,"status":8,"city":305,"state":291,"zip":306,"country":73,"contacts":307,"geoPoint":314},"Washington University in St. Louis","St Louis","63130",[308,312],{"name":309,"role":77,"phone":310,"email":311},"Samuel Williams","314-747-2626","wsamuel@wustl.edu",{"name":313,"role":82},"Douglas Adkins, MD",{"lat":315,"lon":316},38.62727,-90.19789,{"facility":318,"status":8,"city":319,"state":319,"zip":320,"country":73,"contacts":321,"geoPoint":328},"Mount Sinai Hospital","New York","10029",[322,326],{"name":323,"role":77,"phone":324,"email":325},"Julia Miller","212-824-5378","julia.miller@mssm.edu",{"name":327,"role":82},"Kryzsztof Misiukiewicz",{"lat":329,"lon":330},40.71427,-74.00597,{"facility":332,"status":8,"city":333,"state":334,"zip":335,"country":73,"contacts":336,"geoPoint":343},"Sanford Fargo","Fargo","North Dakota","58102",[337,341],{"name":338,"role":77,"phone":339,"email":340},"Signe Harris","701-234-7515","signe.harris@sanfordhealth.org",{"name":342,"role":82},"Daniel Almquist",{"lat":344,"lon":345},46.87719,-96.7898,{"facility":347,"status":8,"city":348,"state":349,"zip":350,"country":73,"contacts":351,"geoPoint":358},"University of Cincinnati","Cincinnati","Ohio","45219",[352,356],{"name":353,"role":77,"phone":354,"email":355},"Shelby Mitchell","513-584-6195","mitchesb@ucmail.uc.edu",{"name":357,"role":82},"Chris Lemmon, MD",{"lat":359,"lon":360},39.12711,-84.51439,{"facility":362,"status":8,"city":363,"state":349,"zip":364,"country":73,"contacts":365,"geoPoint":372},"Cleveland Clinic","Cleveland","44195",[366,370],{"name":367,"role":77,"phone":368,"email":369},"Alfred Kotarja","216-442-1947","kotarja@ccf.org",{"name":371,"role":82},"Shlomo Koyfman",{"lat":373,"lon":374},41.4995,-81.69541,{"facility":376,"status":8,"city":377,"state":349,"zip":378,"country":73,"contacts":379,"geoPoint":386},"Ohio State University","Columbus","43210",[380,384],{"name":381,"role":77,"phone":382,"email":383},"Harley Hamilton","614-293-6522","Harley.Hamilton@osumc.edu",{"name":385,"role":82},"Marcelo Bonomi",{"lat":387,"lon":388},39.96118,-82.99879,{"facility":390,"status":8,"city":391,"state":392,"zip":393,"country":73,"contacts":394,"geoPoint":401},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[395,399],{"name":396,"role":77,"phone":397,"email":398},"Daniel Huth","541-778-0331","Daniel.Huth@PennMedicine.upenn.edu",{"name":400,"role":82},"Lova Sun",{"lat":402,"lon":403},39.95238,-75.16362,{"facility":405,"status":8,"city":406,"state":392,"zip":407,"country":73,"contacts":408,"geoPoint":414},"Cancer Care Associates of York","York","17403",[409,412],{"name":410,"role":77,"email":411},"Clarissa Vega","cvega@cancercareyork.com",{"name":413,"role":82},"Chanh Huynh",{"lat":415,"lon":416},39.9626,-76.72774,{"facility":418,"status":8,"city":419,"state":420,"zip":421,"country":73,"contacts":422,"geoPoint":429},"Sanford Sioux Falls","Sioux Falls","South Dakota","57104",[423,427],{"name":424,"role":77,"phone":425,"email":426},"Brenna Many Horses","605-312-6217","Brenna.Manyhorses@SanfordHealth.org",{"name":428,"role":82},"Steven Powell",{"lat":430,"lon":431},43.54369,-96.72796,{"facility":433,"status":8,"city":434,"state":435,"zip":436,"country":73,"contacts":437,"geoPoint":444},"Vanderbilt University","Nashville","Tennessee","37212",[438,442],{"name":439,"role":77,"phone":440,"email":441},"Ilyana Ilieva","615-936-0960","ilyana.ilieva@vumc.org",{"name":443,"role":82},"Jennifer Choe",{"lat":445,"lon":446},36.16589,-86.78444,{"facility":448,"status":8,"city":449,"state":450,"zip":451,"country":73,"contacts":452,"geoPoint":459},"University of Washington","Seattle","Washington","98109",[453,457],{"name":454,"role":77,"phone":455,"email":456},"Marcus Schoenfeld","206-606-7487","msschoen@fredhutch.org",{"name":458,"role":82},"Cristinia Rodriguez",{"lat":460,"lon":461},47.60621,-122.33207,{"facility":463,"status":8,"city":464,"state":465,"zip":466,"country":73,"contacts":467,"geoPoint":474},"ThedaCare","Appleton","Wisconsin","54911",[468,472],{"name":469,"role":77,"phone":470,"email":471},"Sarah Loether","920-364-3604","sarah.loether@thedacare.org",{"name":473,"role":82},"Matthias Weiss",{"lat":475,"lon":476},44.26193,-88.41538,{"facility":478,"status":479,"city":480,"zip":481,"country":482,"geoPoint":483},"Pan American Cancer for Oncology","ACTIVE_NOT_RECRUITING","San Juan","00909","Puerto Rico",{"lat":484,"lon":485},18.46633,-66.10572,[487],{"name":488,"role":77,"phone":489,"email":490},"Phoenix HNSCC","(833) 514-4187","phoenix@tempus.com",[492],{"name":493,"affiliation":494,"role":495},"Virginia Rhodes, MD","Tempus AI, Inc.","STUDY_DIRECTOR",[497,501,503,506,509,512,515,518,521,524,527,530,533,536,539,542,545,548,551,554,557,560,563,566,569,572,575,578,581],{"pmid":498,"type":499,"citation":500},"34540672","BACKGROUND","Hsieh RW, Borson S, Tsagianni A, Zandberg DP. Immunotherapy in Recurrent\u002FMetastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2021 Sep 1;11:705614. doi: 10.3389\u002Ffonc.2021.705614. eCollection 2021.",{"type":499,"citation":502},"Head and neck cancer - risk factors and prevention. Cancer.Net. Published June 25, 2012. Accessed August 11, 2023. https:\u002F\u002Fwww.cancer.net\u002Fcancer-types\u002Fhead-and-neck-cancer\u002Frisk-factors-and-prevention",{"pmid":504,"type":499,"citation":505},"26046059","Kimple RJ, Harari PM. The prognostic value of HPV in head and neck cancer patients undergoing postoperative chemoradiotherapy. Ann Transl Med. 2015 May;3(Suppl 1):S14. doi: 10.3978\u002Fj.issn.2305-5839.2015.01.37. No abstract available.",{"pmid":507,"type":499,"citation":508},"34069092","Ionna F, Bossi P, Guida A, Alberti A, Muto P, Salzano G, Ottaiano A, Maglitto F, Leopardo D, De Felice M, Longo F, Tafuto S, Della Vittoria Scarpati G, Perri F. Recurrent\u002FMetastatic Squamous Cell Carcinoma of the Head and Neck: A Big and Intriguing Challenge Which May Be Resolved by Integrated Treatments Combining Locoregional and Systemic Therapies. Cancers (Basel). 2021 May 14;13(10):2371. doi: 10.3390\u002Fcancers13102371.",{"pmid":510,"type":499,"citation":511},"29941547","Samra B, Tam E, Baseri B, Shapira I. Checkpoint inhibitors in head and neck cancer: current knowledge and perspectives. J Investig Med. 2018 Oct;66(7):1023-1030. doi: 10.1136\u002Fjim-2018-000743. Epub 2018 Jun 25.",{"pmid":513,"type":499,"citation":514},"18784101","Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056\u002FNEJMoa0802656.",{"pmid":516,"type":499,"citation":517},"31679945","Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016\u002FS0140-6736(19)32591-7. Epub 2019 Nov 1.",{"pmid":519,"type":499,"citation":520},"33076306","Wang HC, Yeh TJ, Chan LP, Hsu CM, Cho SF. Exploration of Feasible Immune Biomarkers for Immune Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinoma Treatment in Real World Clinical Practice. Int J Mol Sci. 2020 Oct 15;21(20):7621. doi: 10.3390\u002Fijms21207621.",{"pmid":522,"type":499,"citation":523},"30115704","Wei SC, Duffy CR, Allison JP. Fundamental Mechanisms of Immune Checkpoint Blockade Therapy. Cancer Discov. 2018 Sep;8(9):1069-1086. doi: 10.1158\u002F2159-8290.CD-18-0367. Epub 2018 Aug 16.",{"pmid":525,"type":499,"citation":526},"30546008","Darvin P, Toor SM, Sasidharan Nair V, Elkord E. Immune checkpoint inhibitors: recent progress and potential biomarkers. Exp Mol Med. 2018 Dec 13;50(12):1-11. doi: 10.1038\u002Fs12276-018-0191-1.",{"pmid":528,"type":499,"citation":529},"36092724","Yu C, Li Q, Zhang Y, Wen ZF, Dong H, Mou Y. Current status and perspective of tumor immunotherapy for head and neck squamous cell carcinoma. Front Cell Dev Biol. 2022 Aug 26;10:941750. doi: 10.3389\u002Ffcell.2022.941750. eCollection 2022.",{"pmid":531,"type":499,"citation":532},"33919778","Kong L, Birkeland AC. Liquid Biopsies in Head and Neck Cancer: Current State and Future Challenges. Cancers (Basel). 2021 Apr 14;13(8):1874. doi: 10.3390\u002Fcancers13081874.",{"pmid":534,"type":499,"citation":535},"26786940","Mazurek AM, Rutkowski T, Fiszer-Kierzkowska A, Malusecka E, Skladowski K. Assessment of the total cfDNA and HPV16\u002F18 detection in plasma samples of head and neck squamous cell carcinoma patients. Oral Oncol. 2016 Mar;54:36-41. doi: 10.1016\u002Fj.oraloncology.2015.12.002. Epub 2016 Jan 11.",{"pmid":537,"type":499,"citation":538},"24553385","Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126\u002Fscitranslmed.3007094.",{"pmid":540,"type":499,"citation":541},"26109104","Wang Y, Springer S, Mulvey CL, Silliman N, Schaefer J, Sausen M, James N, Rettig EM, Guo T, Pickering CR, Bishop JA, Chung CH, Califano JA, Eisele DW, Fakhry C, Gourin CG, Ha PK, Kang H, Kiess A, Koch WM, Myers JN, Quon H, Richmon JD, Sidransky D, Tufano RP, Westra WH, Bettegowda C, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Agrawal N. Detection of somatic mutations and HPV in the saliva and plasma of patients with head and neck squamous cell carcinomas. Sci Transl Med. 2015 Jun 24;7(293):293ra104. doi: 10.1126\u002Fscitranslmed.aaa8507.",{"pmid":543,"type":499,"citation":544},"25078109","Ahn SM, Chan JY, Zhang Z, Wang H, Khan Z, Bishop JA, Westra W, Koch WM, Califano JA. Saliva and plasma quantitative polymerase chain reaction-based detection and surveillance of human papillomavirus-related head and neck cancer. JAMA Otolaryngol Head Neck Surg. 2014 Sep;140(9):846-54. doi: 10.1001\u002Fjamaoto.2014.1338.",{"pmid":546,"type":499,"citation":547},"28792880","Chan KCA, Woo JKS, King A, Zee BCY, Lam WKJ, Chan SL, Chu SWI, Mak C, Tse IOL, Leung SYM, Chan G, Hui EP, Ma BBY, Chiu RWK, Leung SF, van Hasselt AC, Chan ATC, Lo YMD. Analysis of Plasma Epstein-Barr Virus DNA to Screen for Nasopharyngeal Cancer. N Engl J Med. 2017 Aug 10;377(6):513-522. doi: 10.1056\u002FNEJMoa1701717.",{"pmid":549,"type":499,"citation":550},"15928666","Hamana K, Uzawa K, Ogawara K, Shiiba M, Bukawa H, Yokoe H, Tanzawa H. Monitoring of circulating tumour-associated DNA as a prognostic tool for oral squamous cell carcinoma. Br J Cancer. 2005 Jun 20;92(12):2181-4. doi: 10.1038\u002Fsj.bjc.6602635.",{"pmid":552,"type":499,"citation":553},"32017652","Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200\u002FJCO.19.02444. Epub 2020 Feb 4.",{"pmid":555,"type":499,"citation":556},"35740633","Aulakh SS, Silverman DA, Young K, Dennis SK, Birkeland AC. The Promise of Circulating Tumor DNA in Head and Neck Cancer. Cancers (Basel). 2022 Jun 16;14(12):2968. doi: 10.3390\u002Fcancers14122968.",{"pmid":558,"type":499,"citation":559},"34230613","Liebs S, Eder T, Klauschen F, Schutte M, Yaspo ML, Keilholz U, Tinhofer I, Kidess-Sigal E, Braunholz D. 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NPJ Precis Oncol. 2021 Jul 2;5(1):63. doi: 10.1038\u002Fs41698-021-00202-2.",[],{"nct_id":4,"conditions":586,"biomarkers":587},[19],[588],"Programmed Cell Death 1 Ligand 1",{"nct_id":4,"found":590,"summary":591,"prompt_version":601},true,{"design":592,"status":593,"heading":594,"summary":595,"follow_up":596,"word_count":597,"commitments":598,"compensation":599,"drugs_mentioned":600},"This is an observational study, meaning you will receive standard medical care while researchers collect information. It plans to include about 500 participants.","completed","Observational Study for Head & Neck Squamous Cell Carcinoma Biomarkers","This study is looking at people with head and neck squamous cell carcinoma (HNSCC) that has spread or come back and cannot be treated with local therapies. You would be eligible if you are planning to receive anti-PD1 or PDL1 monotherapy or combination therapy as your first treatment. Researchers will collect tissue and blood samples during your regular care to look for specific markers (biomarkers) like PD-L1. The goal is to better understand these biomarkers and how they might predict how well treatments work or how the disease progresses, which could help in developing future treatments. The study aims to enroll about 500 participants and will follow them for 5 years.","Participants will be followed for 5 years to explore various biomarkers.",111,"You would provide tumor tissue and blood samples during your standard medical care. The study will follow you for 5 years.","Not stated in the trial record.",[],"v2"]