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. 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.
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=20).
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).
Trial design
Cohort
Prospective
Treatments tested in this trial
Study sample collection
Procedure/SurgeryBlood draws, urine and tissue asservation, and bone marrow aspiration will be done during surgery
Treatment groups
Trial outcomes
Primary outcomes
CTC/DTC numbers measured in blood, urine and bone marrow samples will be correlated with patient outcome
CTC/DTC numbers in the blood, urine and bone marrow will be determined and correlated with survival data (presence of recurrence, death) by univariate analysis (log rank test), multivariate analysis (Cox regression) and t test/ANOVA
Secondary outcomes
ctDNA characteristics will be correlated with survival data
A panel of ctDNA mutations detected in the blood will be gathered in a score and correlated with survival data (presence of recurrence, death) by univariate analysis (log rank test), multivariate analysis (Cox regression)
Sponsors and contacts
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