CIRculating CANcer MAster-Protocol (CIRCAN MAP)

July 21, 2023 updated by: Hospices Civils de Lyon

MAster Protocol Studying the Impact of Blood Biopsy on Screening, Diagnosis, Diagnostic and Follow-up of Solid Cancer in Adult

This exploratory study will focus on the development of the analyses of blood biomarkers to better understand the circulating biomarkers associated with cancer diagnosis, treatment efficacy and progressive disease

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Service de Pneumologie Hôpital Louis Pradel / Groupement Hospitalier Est
        • Contact:
      • Lyon, France, 69004
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Service de Pneumologie Aigue Spécialisée et Cancérologie Thoracique Hôpital Lyon-Sud / Groupement Hospitalier Sud
        • Contact:
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Oncologie médicale Hôpital Lyon-Sud / Groupement Hospitalier Sud
        • Contact:
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Service de dermatologie Hôpital Lyon-Sud / Groupement Hospitalier Sud
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult with solid cancer

Description

Inclusion Criteria:

  • Adult (>18y)
  • Owing a social security insurance
  • Any solid cancer diagnosed by histopathology or cytology
  • Patient with blood sampling required as per standard of care
  • Informed consent signed

Exclusion Criteria:

  • Refusal to participate
  • No blood sampling required as per standard of care
  • Hemoglobin < 7g/dl (< 9g/dl if respiratory or cardiovascular disease history)
  • Heterologous blood transfusion in the last 48 hours
  • Weight under 20 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult with solid cancer. No intervention.
Biological: Blood sampling for biomarker analysis (microRNA, circulating DNA…)
From one to four blood samplings: at diagnosis, after the first cycle of treatment, end of treatment, progressive disease (or end of study).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liquid biopsy analyses
Time Frame: Day 0
Extraction of circulating DNA or circulating RNA followed by a tumoral cells extraction.
Day 0
Standard technics of disease assessment
Time Frame: Week 16
Genetic and transcriptomic explorations with immunofluorescence technique. Marking with specific markers of the tumor pathology. And enumaration of tumoral cells.
Week 16
Correlation between outcome 1 and outcome 2
Time Frame: year 5
Building a biological collection of blood samples and following, diagnosis and prediction of adult solid cancer.
year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2022

Primary Completion (Estimated)

December 1, 2047

Study Completion (Estimated)

December 1, 2047

Study Registration Dates

First Submitted

October 11, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 22, 2021

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 69HCL21_0918

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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