Observational Study of Tumor Cells and DNA in Cancer Patients

This observational study is looking at how cancer spreads by detecting tumor cells and DNA in blood, urine, and bone marrow. Researchers are using diagnostic tests to look for circulating tumor cells (CTCs), disseminated tumor cells (DTCs), and changes in DNA. The goal is to better understand how cancer spreads and to help develop personalized treatments and improved screening methods. You may be able to join if you are over 18, have been diagnosed with certain solid cancers (like lung, esophageal, gastric, pancreatic, or liver cancer), and are undergoing surgery. The study aims to enroll 320 participants, but its current status is unclear.

Study design
This is an observational study with a planned enrollment of 320 participants. It is not a treatment study but rather focuses on understanding cancer biology.
What's involved
If you are a cancer patient undergoing surgery, bone marrow will be drawn perioperatively. Blood and urine samples will also be collected at baseline.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for this study are measured at baseline, meaning at the start of the study.

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NCT03551951

Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow

Recruiting
Not specifiedAges 18+Observational
University of Missouri-Columbia
~320 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:Test for circulating tumor cells, DNA alterations

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of CTC/DTC in blood
Measured over At baseline
+5 more outcomes measured
Non Small Cell Lung Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Hepatocellular Cancer
Colorectal Cancer
1 sites across 1 states
Missouri1
  • Jussuf T Kaifi, MD · PRINCIPAL_INVESTIGATOR · University of Missouri Health Care

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Eligibility criteria

Inclusion

Subjects older than 18 years.
Subjects of all genders and ethnicities.
Subjects with the diagnosis of a solid cancer (n=100) of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma).
Ten patients with no present suspicion and no previous history of any cancer (except basal cell cancer of the skin) that undergo surgeries for other benign indications will serve as controls (n=10).
In patients undergoing surgery for cancer the histopathology should preferably be pathologically proven by a previous or novel biopsy. Yet, patients with a high cancer suspicion by radiology and clinical picture that undergo cancer surgery will not be excluded. No additional biopsies, testing or interventions will be performed for the purpose of this study if the medical treatment will not require it.
Subjects must be capable of giving informed consent.
Lung cancer screening eligibility criteria (n=100): 55-80 years old, \>30 pack years smoking history, and current smoker or have quit within the last 15 years)

Exclusion

Pregnant women.
Subjects with the concurrent diagnosis of an active secondary (synchronous) malignancy besides basal cell carcinoma of the skin will be excluded, if there is evidence of disease burden or if the patient is currently being treated with chemotherapy.
Subjects with a hemoglobin of \<8g/dl in the morning of the procedure will be excluded.
In subjects who require intraoperative transfusions of \>4 units of red packed blood cells (RPBCs), no further blood will be drawn for CTC/DTC/cfDNA analysis during surgery or on postoperative day 1.
In patients with coagulation disorders that could lead to significant bleeding (such as hemophilia, significant thrombocytopenia) requiring prophylactic administration of coagulative products, no bone marrow aspiration will be performed.
  • Number of CTC/DTC in bloodAt baseline

    Quantify the number of CTC and DTC in urine

  • Number of CTC/DTC in urineAt baseline

    Quantify the number of CTC and DTC in urine

  • Number of CTC/DTC in bone marrowAt baseline

    Quantify the number of CTC and DTC in bone marrow

  • Quantity of cfDNA in bloodAt baseline

    Quantify the amount of cfDNA in blood

  • Quantity of cfDNA in urineAt baseline

    Quantify the amount of cfDNA in urine

  • Quantity of cfDNA in bone marrowAt baseline

    Quantify the amount of cfDNA in bone marrow