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

NCT03551951 | Recruiting DMC

• 1 other identifier: 2004401-VA
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with resectable solid primary cancers and even limited number of metastases are potentially curable. However, most patients develop recurrences despite surgery. Also, early detection of lung cancer with low dose CT screening may cure patients at an early stage. Circulating and disseminated tumor cell (CTC/DTC) and circulating cell-free (cf) DNA isolation from the blood, urine and bone marrow will increase understanding of cancer spread and advance knowledge to develop individualized therapies and improve screening.

Conditions

Non Small Cell Lung Cancer; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Hepatocellular Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (6)

• Number of CTC/DTC in blood

  Quantify the number of CTC and DTC in urine

  At baseline

• Number of CTC/DTC in urine

  Quantify the number of CTC and DTC in urine

  At baseline

• Number of CTC/DTC in bone marrow

  Quantify the number of CTC and DTC in bone marrow

  At baseline

• Quantity of cfDNA in blood

  Quantify the amount of cfDNA in blood

  At baseline

• Quantity of cfDNA in urine

  Quantify the amount of cfDNA in urine

  At baseline

• Quantity of cfDNA in bone marrow

  Quantify the amount of cfDNA in bone marrow

  At baseline

Study Arms (3)

Patients having surgery

Cancer patients undergoing surgery will have test for circulating tumor cells, DNA alterations

Diagnostic Test: Test for circulating tumor cells, DNA alterations

Patients not having surgery

Cancer patients not undergoing surgery (but potentially other treatments) will have test for circulating tumor cells, DNA alterations. Lung cancer screening subjects

Diagnostic Test: Test for circulating tumor cells, DNA alterations

Healthy subjects

Healthy control subjects will have test for circulating tumor cells, DNA alterations

Diagnostic Test: Test for circulating tumor cells, DNA alterations

Interventions

Test for circulating tumor cells, DNA alterations DIAGNOSTIC_TEST

Healthy subjects; Patients having surgery; Patients not having surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with the diagnosis of a solid cancer of all stages will be included (lung, esophageal, stomach, bile duct/pancreas, colorectal, melanoma, sarcoma). Lung cancer screening subjects will also be included (as defined above) Total recruitment: 320

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Harry S. Truman Memorial Veterans' Hospital: collaborator

Study Sites (1)

Harry S Truman Veterans Memorial Hospital

Columbia, Missouri, 65212, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, lymphocyte DNA, urine, bone marrow, cancer tissue, healthy tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jussuf T Kaifi, MD

  University of Missouri Health Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussuf T Kaifi, MD

CONTACT

5738146565; jussuf.kaifi@va.gov

Jussuf T Kaifi, MD

CONTACT

5738146565; kaifij@health.missouri.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Chief, Thoracic Surgery

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 11, 2018
• Study Start: July 1, 2016
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)