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NCT Number: NCT05088395

Analysis of Circulating Tumor mArkers in Blood 4 - ALCINA 4

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie, Paris, France

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About this study

The ALCINA 4 study is a prospective biological cohort study based on the analysis of circulating tumour biomarkers obtained by blood sampling, with comparison - if necessary - with tumour material obtained by biopsy.

Circulating tumour biomarkers in blood have been the subject of much research for several decades, leading to the development in the 1980s of serum protein markers still in use today (CA15.3, ACE, CA125...). In the last decade, research has focused on circulating tumour cells (CTCs), circulating endothelial cells (CECs) and more recently on the detection of circulating tumour DNA (ctDNA) and exosomes (or microvesicles). While ctDNA seems to have a very promising future, other circulating elements such as microRNA are also part of what can/will be studied from a simple blood sample. Broadly speaking, the potential clinical interests of these circulating biomarkers are :

  • diagnostic (diagnosis of cancer, or especially diagnosis of genetic mutations present in a known cancer)
  • prognostic (to adapt the intensity of treatment to the expected outcome of the patient)
  • predictive of the efficacy of targeted therapies (according to the mutational profile of the cancer)
  • to study mechanisms of resistance during treatment . The multiplicity of these potential blood biomarkers is matched by a large number of detection techniques, for example for CTCs or ctDNA.

The major new challenge in research on circulating biomarkers is to replace molecular analyses on tumour tissue obtained by biopsy (e.g. the search for somatic cancer mutations) by a simple blood sample ("liquid biopsy"). This objective, which is technologically possible in the very short term and particularly interesting - both medically (for patients) and economically - requires the comparison of data from blood markers with those from tumour tissue samples. Furthermore, there is an important trend to combine several levels of analysis together (e.g. ctDNA and serum protein markers) to refine the performance of blood tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood sample

Other

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

Other

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

Primary outcomes

  1. Detection rate of circulating biomarkers in cohort 1

    Time frame: Baseline

    Positivity rate of the detection technique (in %)

  2. Detection rate of circulating biomarkers in cohort 2

    Time frame: Baseline

    Positivity rate of the detection technique (in %)

  3. Detection rate of circulating biomarkers in cohort 2

    Time frame: Before treatment

    Positivity rate of the detection technique (in %)

  4. Detection rate of circulating biomarkers in cohort 2

    Time frame: At 3 weeks of treatment

    Positivity rate of the detection technique (in %)

  5. Detection rate of circulating biomarkers in cohort 2

    Time frame: At 9 weeks of treatment

    Positivity rate of the detection technique (in %)

  6. Detection rate of circulating biomarkers in cohort 2

    Time frame: At disease progression

    Positivity rate of the detection technique (in %)

  7. Detection rate of circulating biomarkers in cohort 1

    Time frame: Before surgery

    Positivity rate of the detection technique (in %)

  8. Detection rate of circulating biomarkers in cohort 1

    Time frame: After surgery (from 3 to 5 weeks)

    Positivity rate of the detection technique (in %)

  9. Detection rate of circulating biomarkers in cohort 1

    Time frame: After surgery (from 2 to 3 months)

    Positivity rate of the detection technique (in %)

  10. Detection rate of circulating biomarkers in cohort 3

    Time frame: Baseline

    Positivity rate of the detection technique (in %)

  11. Detection rate of circulating biomarkers in cohort 3

    Time frame: At the end of cycle 1 (each cycle is 21 days)

    Positivity rate of the detection technique (in %)

  12. Detection rate of circulating biomarkers in cohort 3

    Time frame: After surgery (from 2 to 3 months)

    Positivity rate of the detection technique (in %)

  13. Detection rate of circulating biomarkers in cohort 3

    Time frame: At disease progression

    Positivity rate of the detection technique (in %)

  14. Detection rate of circulating biomarkers in cohort 4

    Time frame: At pre-surgery or before starting treatment

    Positivity rate of the detection technique (in %)

  15. Detection rate of circulating biomarkers in cohort 4

    Time frame: At 6 weeks after surgery or after start of treatment

    Positivity rate of the detection technique (in %)

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Emmanuelle LEGRIER

CONTACT

[email protected]

0033156245649

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: ALCINA4

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Oct 21, 2021
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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