Clinical trial · Interventional
Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4
NCT05088395CI-TRIAL-00108165ALCINA4recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Multi-cohort exploratory prospective study. Participation in the ALCINA 4 study does not change the standard management of the patient, including the treatments administered. A sampling schedule will be set up for each cohort. Depending on the clinical context studied and the biomarkers studied and/or sought, the timing of blood samples will vary between cohorts. There may be up to 4 samples (or more) taken per patient for up to 18, 24 or 36 months. If a specific tumor sample is required, it will be collected only once during the study.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Other | — | UNRESOLVED |
| Blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- OTHER
- label
- Cohort 1: "SENOLOC"
- description
- Detecting residual disease after surgery is absolutely crucial in oncology, as this detection could allow the personalisation of post-operative treatments based on the presence of residual disease. The laboratory wishes to develop a new technique for the detection of circulating tumour DNA, based on the recognition of translocation fragments in circulating DNA by shallow whole genome sequencing. This is an original approach, which to our knowledge has not been tested so far with the envisaged bioinformatics approach and could potentially be more sensitive than the techniques currently used to detect residual disease after surgical removal of localised (non-metastatic) breast cancer. The analysis will therefore focus on the search for tumour chromosomal translocations, which will need to be differentiated from possible germline chromosomal translocations. The collection of constitutional DNA is therefore planned in this cohort.
- interventionNames
- Other: Blood sample
- type
- OTHER
- label
- Cohort 2: "Immuno-TNBC "
- description
- The aim for this cohort is to study the role that variations in circulating tumour DNA might have as a marker associated with response during chemoimmunotherapy. A fresh biopsy (subsequently stored frozen) is required for mutational profiling analysis (which will be used to track circulating tumour DNA in the blood). In addition, it will be used to analyse currently recognised biological tissue factors of response to chemoimmunotherapy (PD-L1 labelling, mutational load, ...) and to identify possible associations with circulating tumour DNA variations. Constitutional DNA analysis is necessary for the determination of point mutations present in the tumour (to be differentiated from polymorphisms present at the constitutional level), as the determination of these mutations is essential to monitor circulating tumour DNA and will therefore be collected.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient treated for cancer at one of the participating center * 18 years old or higher * Signed informed consent form * Patient not deprived of their liberty or under guardianship (including temporary guardianship) * Patient covered by social security scheme * Patient with no compliance issue (related to geographical, social or psychological reasons) for study follow up * Other additional criteria will be defined (defining tumor type and clinical setting), by cohort If a biopsy tumor sample is to be taken: * Tumor considered as accessible by biopsy (at the investigator's discretion). * Normal blood coagulation tests (if applicable, and in case of a non-superficial tumor lesion). * No anticoagulant or antiaggregant treatment for the biopsy. Exclusion Criteria : Pregnant and/or breast-feeding women depending on cohort.
References
Publications (0)
Data not yet available
No reference posted for this study.