Clinical trial · Observational
Genetic Mutations in Blood and Tissue Samples in Predicting Response to Treatment in Patients With Locally Advanced Rectal Cancer Undergoing Chemoradiation
Assessing Intratumoral Heterogeneity and Chemoradiation Response in Locally Advanced Rectal Cancer Utilizing Sequencing and PET/CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research trial studies genetic mutations in blood and tissue samples to see if they can be used to predict treatment response in patients with locally advanced rectal cancer undergoing chemoradiation. Studying samples of blood and tumor tissue in the laboratory from patients with cancer may help doctors learn more about genetic mutations or changes that occur in deoxyribonucleic acid (DNA) and help doctors understand how patients respond to treatment.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucinous Adenocarcinoma of the Rectum | Rectal Mucinous Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Signet Ring Adenocarcinoma of the Rectum | Rectal Signet Ring Cell Adenocarcinoma | ALIAS | 0.90 |
| Stage IIA Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-Correlative (genetic mutation analysis)
- description
- Patients undergo collection of blood and tissue samples for analysis via sequencing.
- interventionNames
- Other: cytology specimen collection procedure
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Proportion of the randomly chosen samples that are successfully sequenced
- timeFrame
- Up to 3 years
- description
- If \>= 90% of the specimens (at least 72 out of 80) are useable, the method will be considered feasible.
- measure
- Tumor response measured using the tumor regression grading system
- timeFrame
- Up to 3 years
- description
- Whether mutations in any gene on the CancerCode mutation panel are associated with tumor response will be assessed. In each sample, the presence or absence of mutations (0/1) for each gene on the panel will be evaluated. Each gene will be tested separately for its association with tumor response using a two-sample Mann-Whitney-Wilcoxon test with a type-I error of 0.05 for a two-sided test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced rectal adenocarcinoma: T3-4NanyM0 or TanyN1-2M0 * Radiologically measurable or clinically evaluable disease * Provide informed written consent * Willing to return to enrolling medical site for all study assessments Exclusion Criteria: * Chemotherapy within 5 years prior to registration; (hormonal therapy is allowable if the disease free interval is \>= 5 years) * Any prior pelvic radiation * Patients who are at high risk of complications from temporarily discontinuing anticoagulation for rectal cancer biopsies
References
Publications (0)
Data not yet available