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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02407561 |
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Date of registration:
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26/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays
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Scientific title:
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Prospective Validation Study Under CLIA-compliant SOPs for the Proprietary Rectal and Anal Cancer Protein Expression Assays |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02407561 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert Cook, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Castle Biosciences Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anal Squamous Cell Carcinoma
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Rectal Adenocarcinoma
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Anal Adenocarcinoma
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Primary Outcome(s)
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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]
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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]
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Secondary ID(s)
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Protocol_CBI_RC_PVS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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