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

NCT02407561 | Terminated

• 1 other identifier: Protocol_CBI_RC_PVS
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Adenocarcinoma; Anal Adenocarcinoma; Anal Squamous Cell Carcinoma

Keywords

rectal; adenocarcinoma; DecisionDx

Outcome Measures

Primary Outcomes (2)

• 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.

  Post treatment tissue will be reviewed by independent pathologist for Treatment Response grade.

  at time of surgical resection (visit 3) - review of resected tumor

• Gene expression profiling will be undertaken to determine if RNA is a superior biomarker to protein

  once testing done the results will be compared to the resection Treatment Response grade determined by pathologist.

  at time of enrollment (visit 1) tissue will be sent for testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with newly diagnosed rectal adenocarcinoma, or anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to surgery.

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

Sponsors & Collaborators

• Castle Biosciences Incorporated: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin Fixed Paraffin Embedded (FFPE) H\&E stained tumor samples(biopsy and resection) cDNA- tumor sample IHC Stained FFPE- tumor samples

MeSH Terms

Conditions

Rectal Neoplasms; Anus Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Robert Cook, PhD

  Castle Biosciences Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 3, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 25, 2018

Record last verified: 2016-07

Locations

US (1)