Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT02407561
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02407561
Study Brief:
Protocol Section:
NCT02407561