Clinical trial · Observational
A Study of the Role of Circulating Tumor DNA in Predicting the Likelihood of Organ Preservation After Clinical Complete Response to Neoadjuvant Therapy for Rectal Cancer
NCT03749083CI-TRIAL-00039381withdrawnClinicalTrials.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): Funding
Summary
Brief summary (as posted)
In this research study, the investigators are looking to see if the circulating tumor DNA (genetic material), also known as ctDNA, in the blood will help them predict whether the participant's cancer will come back.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The Functional Assessment of Cancer Therapy- Colorectal | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tumor Sequencing
- description
- * Quality of life assessments will be collected using The Functional Assessment of Cancer Therapy- Colorectal * Blood for circulating tumor DNA will be collected
- interventionNames
- Other: The Functional Assessment of Cancer Therapy- Colorectal
Primary outcomes (1)
- measure
- One year local recurrence rate in participants that test positive for ctDNA compared to participants that tested negative for ctDNA
- timeFrame
- 1 year
- description
- Local recurrence will be defined as recurrence of the pathologically confirmed adenocarcinoma. This may be detected by endoscopy for intraluminal recurrence or after radical surgery for radiographic evidence of extraluminal/mesorectal recurrence. The recurrence must be in the peri-anastomic site or rectal stump, or pre-sacral area. Regional nodal recurrence and lateral pelvic lymph node recurrence of rectal cancer are also included in this definition.
Secondary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have achieved a clinical complete response (cCR) within 3 months of last therapy - defined as absence of residual ulceration, mass or mucosal irregularity at endoscopic assessment - following neoadjuvant therapy with chemoradiation or chemotherapy followed by radiation for stage I, II, or III non-metastatic rectal cancer. (Whitening of the mucosa with presence of telangiectasia will be accepted as cCR.) * Participants must have original tumor tissue (formalin-fixed, paraffin-embedded specimens) available for analysis * Participants must be 18 years of age or older. * Participants must be able to understand and willing to sign a written informed consent document. * Participants must have received long course chemoradiation to 40-54 Gy. * Participants must have received at least 4 cycles of FOLFOX * Participant must be no more than 3 months past the conclusion of initial chemoradiation of rectal cancer (i.e., end of chemoradiation). Exclusion Criteria: * Participants may 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.
References
Publications (0)
Data not yet available
No reference posted for this study.