A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Live… (NCT03432806) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
United States51 participantsStarted 2017-11-28
Plain-language summary
The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria:
* Operation for presumed stage I-IV colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of HAIP)
* Colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas)
* Open, laparoscopic, or robotic resections
* ≥18 years old
Exclusion Criteria:
* Extrahepatic CRC metastasis
* No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma.
* Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy.
* Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an exclusion criterion.
* History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer)
* Colon cancer with microsatellite instability (MSI-high) if known preoperatively
* Known hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
* Known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.