Detection of tumor cells and DNA in blood, urine, and bone marrow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enhance the understanding of cancer spread by isolating circulating and disseminated tumor cells (CTC/DTC) and circulating cell-free DNA (cfDNA) from patients with solid primary cancers and high-risk individuals. It will involve 100 cancer patients and 200 high-risk individuals undergoing lung cancer screening, utilizing innovative techniques for sample collection. The study will analyze genetic alterations and key biomarkers to develop individualized therapies and improve early detection methods for lung cancer. The research will also explore the biological behavior of these liquid biomarkers in both early and advanced cancer stages.

Why it matters

Who can join: the full rules

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=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 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 it's running

• Harry S Truman Veterans Memorial Hospital
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: Jussuf T Kaifi, MD — University of Missouri Health Care
• Study coordinator: Jussuf T Kaifi, MD
• Email: jussuf.kaifi@va.gov
• Phone: 5738146565

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.