Clinical trial · Observational
ctDNA and Organ Preservation/Pathologic CR in Rectal Cancer
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation or Pathologic Complete Response After Neoadjuvant Therapy for Rectal Cancer
- 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 prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy. This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Metastatic Rectal Cancer | Rectal Neoplasm | PROBABILISTIC | 0.70 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EVALUATION OF CTDNA
- description
- This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care \- Except for the initial research biopsy, quality of life assessments and ctDNA collection
- interventionNames
- Other: ctDNA
Primary outcomes (2)
- measure
- Rate of successful non-operative management
- timeFrame
- 1 year
- measure
- Rate of successful pathologic complete response
- timeFrame
- 1 year
Secondary outcomes (10)
- measure
- Rate of local recurrence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with T3, T4, or node-positive non-metastatic rectal cancer. * Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy. * Participants must be 18 years of age or older. * ECOG 0-2. * Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX * Participants must be eligible for long course chemoradiation to 40-54 Gy. * Participants must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Participants must not have any other organ cancer evident at the time of enrollment. * Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate. * Participants must not be actively or planning to be pregnant or breastfeeding
References
Publications (0)
Data not yet available