Detection of tumor cells and DNA in blood, urine, and bone marrow of cancer patients
Tumor Cell and DNA Detection in the Blood, Urine and Bone Marrow of Patients With Solid Cancers
This study is testing if collecting and analyzing tumor cells and DNA from the blood, urine, and bone marrow of cancer patients can help us understand how cancer spreads and comes back, with the hope of creating better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 620 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT02838836 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and analyze circulating tumor cells (CTCs), disseminated tumor cells (DTCs), and circulating cell-free DNA (cfDNA) from patients undergoing surgery for solid cancers. By isolating these biomarkers from blood, urine, and bone marrow, the study seeks to enhance understanding of cancer spread and recurrence. The research will involve 100 patients with solid tumors and 20 control patients with benign conditions, focusing on genetic alterations and the biological behavior of these cancer markers. The findings may lead to the development of personalized therapies for cancer treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with solid cancers such as non-small cell lung cancer, esophageal cancer, gastric cancer, pancreatic cancer, or hepatocellular cancer.
Not a fit: Patients who are pregnant or have concurrent diseases that may interfere with the study's objectives may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to more effective, individualized cancer therapies and improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for cancer detection and monitoring, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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=20). * 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. Exclusion Criteria: * 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.
Where this trial is running
Columbia, Missouri
- Ellis Fischel Cancer Center, University of Missouri — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Jussuf T Kaifi, MD, PhD — Ellis Fischel Cancer Center, University of Missouri
- Study coordinator: Jussuf T Kaifi, MD, PhD
- Email: kaifij@health.missouri.edu
- Phone: 5738828445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.