NCT03551951 Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
| NCT ID | NCT03551951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Non Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2016-07-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2016-07-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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=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.
Contact & Investigator
Jussuf T Kaifi, MD
PRINCIPAL INVESTIGATOR
University of Missouri Health Care
Frequently Asked Questions
Who can join the NCT03551951 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03551951 currently recruiting?
Yes, NCT03551951 is actively recruiting participants. Contact the research team at jussuf.kaifi@va.gov for enrollment information.
Where is the NCT03551951 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT03551951 clinical trial?
NCT03551951 is sponsored by University of Missouri-Columbia. The principal investigator is Jussuf T Kaifi, MD at University of Missouri Health Care. The trial plans to enroll 320 participants.
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