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Clinical Trials in France / NCT05088395
Recruiting Not applicable

Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

NCT05088395 · tracked via the Priya Life Science France tracker
Sponsor
Institut Curie
Phase
Not applicable
Started
2022-05-19
Last updated
2026-04-14

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

Blood sampleBiopsy

Blood sample: 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 according to the cohorts.

Biopsy: If a specific tumor sample is required, it will be collected only once during the study

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Detection rate of circulating biomarkers in cohort 1 — Baseline
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 2 — Baseline
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 2 — Before treatment
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 2 — At 3 weeks of treatment
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 2 — At 9 weeks of treatment
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 2 — At disease progression
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 1 — Before surgery
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 1 — After surgery (from 3 to 5 weeks)
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 1 — After surgery (from 2 to 3 months)
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 3 — Baseline
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 3 — At the end of cycle 1 (each cycle is 21 days)
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 3 — After surgery (from 2 to 3 months)
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 3 — At disease progression
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 4 — At pre-surgery or before starting treatment
    Positivity rate of the detection technique (in %)
  • Detection rate of circulating biomarkers in cohort 4 — At 6 weeks after surgery or after start of treatment
    Positivity rate of the detection technique (in %)

Trial sites (2)

FacilityCityRegionStatus
Institut Curie Paris France Recruiting
Institut Curie Saint-Cloud France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05088395 on ClinicalTrials.gov ↗ ← All trials in France