An observational study in Colonic Neoplasms, sponsored by Scripps Translational Science Institute. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Scripps Translational Science Institute · Observational
The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.
In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's enrollment of 26 is below the median of 262 across 363 observational studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Scripps Translational Science Institute is the lead sponsor of 53 studies on the registry; 13 are open to participants now.
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Patients with colorectal cancer that will be receiving surgical removal of their cancer as part of their care.
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Exclusion Criteria:
All subjects enrolled in the study will provide tumor and normal tissue and blood samples.
Determining sensitivity of assay in known cancer patients
The sensitivity (% positive out of all diseased patients) of circulating tumor DNA detection from the blood samples will be calculated against the gold standard of surgical pathology reports in this pilot group of patients with known colorectal cancer.
Time frame: 2 years
No study locations are listed for this record.
The record gives a start of Jun 2015, a primary completion of Feb 2017 and a completion of Mar 2020. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Scripps Translational Science Institute