About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Test for circulating tumor cells, DNA alterations
Diagnostic test
Treatment groups
Trial outcomes
Primary outcomes
Number of CTC/DTC in blood
Quantify the number of CTC and DTC in urine
Number of CTC/DTC in urine
Quantify the number of CTC and DTC in urine
Number of CTC/DTC in bone marrow
Quantify the number of CTC and DTC in bone marrow
Quantity of cfDNA in blood
Quantify the amount of cfDNA in blood
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Missouri-Columbia
Lead sponsor
Harry S. Truman Memorial Veterans' Hospital
Collaborator