Clinical trial · Interventional
Liquid Biopsies and IMAging for Improved Cancer Care
Liquid Biopsies and IMAging for Improved Cancer Care - Non Metastatic 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)
The recently developed liquid biopsy technology (to obtain and characterize tumour cells and tumour components like Deoxyribonucleic acid (DNA) or Ribonucleic Acid (RNA) from a simple blood draw), in combination with advanced Magnetic Resonance Imaging techniques (MRI), can tackle the following problems in rectal cancer: 1. Assessment of tumour heterogeneity from liquid biopsies. 2. Assessment from advanced MRI feature extraction to indicate poor outcome 3. Faster assessment of therapy response in Neoadjuvant chemotherapy (NAT) for rectal cancer; 4. Detection of emerging drug/therapy resistance. This project's overall objective is to develop and validate technologies and tools to include liquid biopsies in the clinical workflow, aiming at introducing a more precise and dynamic genetic characterization of tumour at the diagnosis and during treatment phases.
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 |
|---|---|---|---|
| Biological collection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumors and blood collection
- description
- For all the patients included in the study : * Blood samples will be collected at different times T1 (Baseline), T2 (1 or 2 weeks after the beginning of the treatment), T3 (3 or 4 weeks before the surgery) and T4 (1 month after the surgery). * Tumors biopsy will be collected for some patients who will benefit from an initial biopsy in the course of his management care in our Institute (before the surgery). In parallel to this biological collection, imaging and clinical data will be entered into a database treatment.
- interventionNames
- Biological: Biological collection
Primary outcomes (1)
- measure
- Area under the Receiver Operating Characteristic (ROC) curve of total cfDNA (defined as circulating cell-free DNA in plasma) percent change between the baseline sample (T1) and the sample at the end of the neo-adjuvant treatment (T3)
- timeFrame
- Through study completion, an average of 3.5 years
- description
- This change of circulating free DeoxyriboNucleic Acid (cfDNA) percent will be correlated with the pathological complete response (defined as Grade 3 and 4 of Dworak definition) to neo-adjuvant treatment Pathological response (at surgery) is defined as Dworak definition below: * No regression (0), * Predominantly tumour with significant fibrosis and/or vasculopathy (1), * Predominantly fibrosis with scattered tumour cells (slightly recognizable histologically) (2), * Only scattered tumour cells in the space of fibrosis with / without acellular mucin (3) * No vital tumour cells detectable (4).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old 2. Histologically-confirmed diagnosis of adenocarcinoma of the rectum 3. Distal part of the tumour within 2 to 12 cm of the anal margin 4. Candidate for Neoadjuvant chemotherapy (NAT) 5. Measurable disease (using the Recist criteria v1.1) 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 7. General condition considered suitable for radical pelvic surgery 8. Adequate bone marrow, hepatic and renal function 9. Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules 10. Patient being able to follow all the treatment as well as the follow-ups planned in this study Exclusion Criteria: 1. Patient with metastatic disease 2. Symptomatic cardiac or coronary insufficiency 3. Severe renal insufficiency 4. Progressive active infection or any other severe medical condition 5. Other cancer treated within the last 5 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma 6. Pregnant or breast-feeding woman 7. Unaffiliated patient to French Social Protection System 8. Persons deprived of liberty or under guardianship or incapable of giving consent 9. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
References
Publications (0)
Data not yet available