Clinical trial · Observational
Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer
A Prospective Observational Study to Determine the Feasibility of Tumor Response Assessment by Circulating Tumor DNA in Patients With Locally Advanced Rectal Cancer Undergoing Total Neoadjuvant Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accrual.
Summary
Brief summary (as posted)
This is a single-arm observational study to determine the feasibility of assessing tumor response utilizing Circulating tumor DNA (ctDNA) in patients of with locally advanced rectal cancer (LARC) undergoing standard-of-care total neoadjuvant therapy (TNT) consisting of systemic chemotherapy (modified FOLFOX or modified FOLFIRINOX) followed by concurrent chemoradiation (50.4 Gy over approximately six weeks with concurrent radiosensitizing dose of capecitabine/5-fluorouracil).
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating tumor DNA(ctDNA) level measurement | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Locally advanced rectal cancer patients
- description
- Patients with LARC undergoing TNT.
- interventionNames
- Diagnostic Test: Circulating tumor DNA(ctDNA) level measurement
Primary outcomes (1)
- measure
- Mean serum ctDNA concentration
- timeFrame
- Baseline, 8 weeks, 16 weeks, around 24 weeks before rectal surgery.
- description
- This measure is the concentration of ctDNA in plasma expressed as mean tumor molecules (MTM)/ml at specific time points.
Secondary outcomes (2)
- measure
- Response based on serum ctDNA level (change from baseline)
- timeFrame
- Baseline, 8 weeks, 16 weeks, around 24 weeks before rectal surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically or cytologically documented rectal cancer eligible for total neoadjuvant therapy (TNT). 2. Male or female subjects ≥18 years old. 3. Rectal tumor biopsy is available for SignateraTM assay development for ctDNA measurement. 4. Patients must be able to understand the informed consent form and provide written consent. Exclusion Criteria: 1. Patients without available rectal biopsy tissue for SignateraTM assay development. 2. Patients with rectal cancer not eligible to receive standard-of-care TNT for any reason. 3. Patients with undetectable ctDNA level in the baseline blood sample. 4. Patients without trackable mutation in the rectal tumor.
References
Publications (1)
- RESULTReinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528. PMID 31070691