Clinical trial · Observational
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
NCT05356585CI-TRIAL-00075992withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor already published research that was to be obtained from this study.
Summary
Brief summary (as posted)
The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells. The tumor DNA fragments are referred to as circulating tumor DNA, or ctDNA for short.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SignateraTM assay | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Detectable ctDNA at the Completion of TNT
- timeFrame
- up to 24 months after TNT
- description
- The percentage of participants with detectable ctDNA at the completion of TNT
Secondary outcomes (2)
- measure
- Change in ctDNA
- timeFrame
- up to 24 months after TNT
- description
- The change in ctDNA (continuous and categorical positive/negative) during and at the end of neoadjuvant chemoradiation and with chemotherapy will be measured. Continuous measurements will be summarized using medians and ranges. Categorical factors will be summarized using frequencies and percentages. Changes in ctDNA will be analyzed by using the Mann-Whitney U test or the Fisher's exact test for continuous or categorical variables, respectively.
- measure
- Correlation of Complete Response TNT
- timeFrame
- Up to 24 months after TNT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly histologically documented rectal adenocarcinoma or biopsy-proven adenoma with MRI rectum and CT chest/abdomen or PET/CT imaging consistent with stage II or III disease * Plan is for participant to undergo standard TNT with induction chemoradiation * Age ≥ 18 years of age Exclusion Criteria: * Stage I, recurrent, or metastatic rectal cancer * Received prior therapy for this rectal cancer * No baseline tumor biopsies with adenocarcinoma or adequate amount of tissue from biopsies available to send for SignateraTM assay development
References
Publications (0)
Data not yet available
No reference posted for this study.