Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays

Stopped early

Conditions studied: Rectal Adenocarcinoma, Anal Adenocarcinoma, Anal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT02407561

Run by

Castle Biosciences Incorporated

People needed

3

Starts

2015-02-01

Expected to finish

2016-07-01

Last updated by the study team

2018-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with histologically confirmed stage II and III rectal adenocarcinoma or subjects with histologically confirmed stage II and III anal SCC
• Subjects greater than 18 years of age.
• Subjects who will undergo prescribed neoadjuvant chemotherapy and/or radiotherapy and have surgical resection prior to further treatment or pathologic confirmation of treatment response using endoscopy or ultrasound.
• Subjects with:
• twenty (20) unstained sections on charged slides available from tumor block (FFPE) used for the diagnosis of rectal/anal carcinoma or adjacent to this block (pre-neoadjuvant biopsy sample); and
• four (4) unstained slides available from post-chemoradiation surgery to allow for blinded pathology review and assessment of pathCR, partial CR, or exCTRT. Slides from surgical resection are not necessary in cases with documented post-surgical determination of response by ultrasound or endoscopy.
• Subjects willing to complete study follow up for outcomes.
• Subjects from who informed consent can be obtained.

You may not qualify if…

• Subjects with carcinoma in situ or Stage I rectal/anal carcinoma.
• Subjects with Stage IV rectal/anal carcinoma.
• Subjects with diagnosis of other malignant tumors with the exception of non-melanoma skin cancers cured by resection only.
• Subjects that have received prior chest or upper abdomen radiotherapy and/or system chemotherapy within the past 5 years
• Subjects who are unwilling to complete study follow up
• Employees and family members of Investigator

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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