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InAdvance: Understanding Cancer Risk and Early Detection

This observational study, called InAdvance, aims to collect and store samples and information from people who have a higher chance of getting cancer, have been diagnosed with early cancer, or have a family history of cancer. The study is looking for clinical, molecular (changes at the genetic level), and pathological (disease-related) changes that could help predict when cancer might develop, how it might progress, and if it could become life-threatening. The goal is to find new ways to detect cancer early and identify who is most at risk, which could lead to new treatments to stop cancer before it becomes serious. About 5,000 people are expected to join this study. You may be able to join if you have a hereditary risk for cancer, including carriers of certain gene changes, or a personal or family history of conditions that increase cancer risk.

Study design
This is an observational study, meaning researchers will collect information and samples without giving any specific treatments. Approximately 5,000 participants are planned for enrollment.
What's involved
Tissue samples like blood, saliva, urine, stool, or biopsy tissue will be collected during routine visits or specifically for research. These materials will be used for molecular and other types of analyses.
Compensation
Not stated in the trial record.
Follow-up
The study aims to identify changes that can predict cancer development and progression, measured at 5 years.

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NCT05463796

InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer

Recruiting
Not specifiedAll AgesObservational
Dana-Farber Cancer Institute
~5,000 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Samples

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.
Measured over 5 years

Conditions

Cancer Risk
Cancer Predisposition Syndrome
Hereditary Cancer Prediction
Childhood Cancer Survivors
Adult Cancer Survivors
IARC Carcinogens
Smoking History
Lung Cancer
Ductal/Lobular Carcinoma
Barrett Esophagus
Pancreatic Precursor Lesions
Colonic Dysplasia/Adenomata
Non-Alcoholic Fatty Liver Disease
Non Alcoholic Steatohepatitis
Cirrhosis
High Grade Prostatic Epithelial Neoplasia
High-grade Bladder Urothelial Dysplasia/Carcinoma in Situ
Adenomatous Hyperplasia
High-risk Oral Precancerous Diseases
Melanocytic Lesion, Adult
Hematologic Malignancy
Lung; Node
Serous Tubal Intraepithelial Carcinoma
Endometrial Intraepithelial Neoplasia
Cervical and Endocervical Carcinoma in Situ
Vulvar Intraepithelial Neoplasia
Nephrogenic Rests
Benign Bone Lesions With Risk of Malignant Degeneration
Giant Cell Tumor
Osteochondroma
Spitz Nevus

Explore related trials

Adult CancerBarrett EsophagusBenign Bone LesionsBladder CarcinomaBreast CarcinomaCancer RiskChildhood Malignant NeoplasmCirrhosisColon DysplasiaEndometrial Atypical Hyperplasia/Endometrioid Intraepithelial NeoplasiaLung CarcinomaMalignant neoplasm of lymphoid, hematopoietic and/or related tissueMelanocytic LesionNephrogenic RestNonalcoholic Fatty Liver DiseaseOral Precancerous DiseasesPancreatic Precursor LesionsPredisposition to Malignant NeoplasmProstate CarcinomaSpitz NevusStage 0 Cervical Cancer AJCC v7Vulvar Intraepithelial Neoplasia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Sapna Syngal, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Jenna Beckwith, MPH
[email protected]
857-215-1892
Email the study team

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Eligibility criteria

Inclusion

Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):
Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes
Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)
Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)
Hereditary Cancer Prediction Model-based elevated cancer risk
Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc.
Exposed High Risk including
Childhood cancer survivors with treatment exposures associated with increased risk of cancer
Adult cancer survivors with treatment exposures associated with increased risk of cancer
Documented high level exposure to group 1 IARC carcinogens
Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age \>50, Smoking history of \>15 pack years, First-degree relative history of lung cancer or COPD
alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis
Precursor Lesions including
Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia
GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis
GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ,
Lung: Adenomatous hyperplasia
H\&N: high-risk oral precancerous diseases
Skin: Class II melanocytic lesions. Squamous dysplasia
Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas
Thoracic: Lung nodules detected on screening CT that prompt further follow-up
GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia
Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.
FAMILY MEMBERS or healthy individuals

What this trial measures

  • Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.5 years

    The InAdvance Study will screen participants for precancerous conditions and cancer through blood tests and tissue biopsies. These biologic samples will be screened for precancerous conditions through routine clinical methods, as well as using novel research level technology. This could include germline testing, whole genome and whole exome sequencing. The participants will be followed serially to track their disease progression. Participants will fill out general health questionnaires, and we will match their answers to the timepoint of their sample submission and follow changes to their answers.