Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays
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|ClinicalTrials.gov Identifier: NCT02407561|
Recruitment Status : Terminated (Futility - unable to secure sites and samples for participation)
First Posted : April 3, 2015
Last Update Posted : January 25, 2018
Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant chemoradiation therapy prior to surgical resection. While response rates to this treatment differ among these three cancers, generally 20-25% of patients exhibit minimal or no response to preoperative chemoradiation therapy while 20-30% exhibit a complete pathologic response, and the remainder receiving a partial response.
This will be a multi-center study of patients with newly diagnosed rectal adenocarcinoma, or anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to surgery. The tumor from these patients will be tested to determine whether response to neoadjuvant chemoradiation can be accurately predicted.
|Condition or disease|
|Rectal Adenocarcinoma Anal Adenocarcinoma Anal Squamous Cell Carcinoma|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||3 participants|
|Official Title:||Prospective Validation Study Under CLIA-compliant SOPs for the Proprietary Rectal and Anal Cancer Protein Expression Assays|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
- Validate the proprietary rectal and anal carcinoma immunohistochemistry protocols under CLIA compliant SOPs, in order to predict response to pre-operative chemoradiation treatment for patients with rectal/ anal carcinoma. [ Time Frame: at time of surgical resection (visit 3) - review of resected tumor ]Post treatment tissue will be reviewed by independent pathologist for Treatment Response grade.
- Gene expression profiling will be undertaken to determine if RNA is a superior biomarker to protein [ Time Frame: at time of enrollment (visit 1) tissue will be sent for testing ]once testing done the results will be compared to the resection Treatment Response grade determined by pathologist.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407561
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Robert Cook, PhD||Castle Biosciences Inc.|