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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Castle Biosciences Incorporated

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.

Condition or disease
Rectal Adenocarcinoma Anal Adenocarcinoma Anal Squamous Cell Carcinoma

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Primary Outcome Measures :
  1. 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.

  2. 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
Formalin Fixed Paraffin Embedded (FFPE) H&E stained tumor samples(biopsy and resection) cDNA- tumor sample IHC Stained FFPE- tumor samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  1. Subjects with histologically confirmed stage II and III rectal adenocarcinoma or subjects with histologically confirmed stage II and III anal SCC
  2. Subjects greater than 18 years of age.
  3. 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.
  4. 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.
  5. Subjects willing to complete study follow up for outcomes.
  6. Subjects from who informed consent can be obtained.

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02407561

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Castle Biosciences Incorporated
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Principal Investigator: Robert Cook, PhD Castle Biosciences Inc.

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Responsible Party: Castle Biosciences Incorporated Identifier: NCT02407561     History of Changes
Other Study ID Numbers: Protocol_CBI_RC_PVS
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: July 2016

Keywords provided by Castle Biosciences Incorporated:

Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Anus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases