Clinical trial · Observational
Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays
Prospective Validation Study Under CLIA-compliant SOPs for the Proprietary Rectal and Anal Cancer Protein Expression Assays
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Futility - unable to secure sites and samples for participation
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Adenocarcinoma | Anal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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.
- timeFrame
- at time of surgical resection (visit 3) - review of resected tumor
- description
- Post treatment tissue will be reviewed by independent pathologist for Treatment Response grade.
- measure
- Gene expression profiling will be undertaken to determine if RNA is a superior biomarker to protein
- timeFrame
- at time of enrollment (visit 1) tissue will be sent for testing
- description
- once testing done the results will be compared to the resection Treatment Response grade determined by pathologist.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available