Clinical trial · Observational
Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
This study measures the levels of circulating tumor DNA (ctDNA) in patients with stage II-III rectal cancer before, during, and after treatment to find out if the presence or absence of ctDNA in patient's blood using the Signatera test can be used to gauge how different treatments may affect rectal cancer. ctDNA is DNA from the rectal cancer that is circulating in the blood. The purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctDNA.
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 |
|---|---|---|---|
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Rectal Cancer AJCC v8 | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection, medical record review)
- description
- Patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing TNT, and then every 3 months for up to 3 years after completion of TNT. Patients' medical records are also reviewed. Patients may undergo collection of tissue sample if an archival tissue sample is not available.
- interventionNames
- Procedure: Biopsy
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
Primary outcomes (1)
- measure
- Complete clinical response (cCR)
- timeFrame
- From time of treatment start up to date of completing total neoadjuvant therapy (TNT), up to 3 months.
- description
- cCR following TNT will be analyzed using the TNT analysis set. Proportions of participants that achieved cCR will be calculated and the exact 95% confidence interval (CI) will be presented.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants aged \>= 18 years * Pathologically-confirmed stage II or III primary adenocarcinoma of the rectum: * T3N0M0 - T4bN2M0 Exclusion Criteria: * Has radiologic evidence of distant metastases at the time of screening/enrollment * Has received prior treatment for their rectal adenocarcinoma * Requires or has received blood transfusion within 1 month of study enrollment
References
Publications (0)
Data not yet available