Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy (BIO-TIMER)

September 26, 2024 updated by: University Hospital, Clermont-Ferrand

Value of Biological Age, in Addition to Individual Frailty, for Personalising the Management of Cancer Treated with Targeted Therapy: the Model of Chronic Myeloid Leukemia Treated with Tyrosine Kinase Inhibitors.

French prospective multicenter, open-label study involving newly diagnosed CML patients. Two assessments will be performed during the follow-up of these patients: individual frailty using geriatric tools and individual biological aging determined by DNA methylation analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Annecy, France
        • Recruiting
        • CHU Annecy-Genevois
        • Contact:
          • Anne PARRY, MD
      • Bordeaux, France
        • Not yet recruiting
        • Institut Bergonie
        • Contact:
          • Gabriel ETIENNE, MD
      • Caen, France
        • Recruiting
        • CHU Caen
        • Contact:
          • Atchroue JOHNSON ANSAH, MD
      • Clermont-Ferrand, France, 63000
      • Créteil, France
        • Not yet recruiting
        • CHU CRETEIL
        • Contact:
          • Lydia ROY, MD
      • Grenoble, France
        • Not yet recruiting
        • CHU Grenoble Alpes
        • Contact:
          • Mathieu MEUNIER, MD
      • Le Puy-en-Velay, France
        • Recruiting
        • Centre Hospitalier Emile Roux
        • Contact:
          • Vanessa PANTE, MD
        • Contact:
          • Vanessa PANTE, Dr
      • Lille, France
        • Not yet recruiting
        • CHRU Lille
        • Contact:
          • valérie Coiteux, md
      • Limoges, France
        • Recruiting
        • CHU Limoges
        • Contact:
          • Amélie PENOT, MD
        • Contact:
          • Jean Baptiste FARGEAS, MD
      • Lyon, France
        • Withdrawn
        • Centre Léon Bérard
      • Marseille, France
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
          • Aude Charbonnier, MD
      • Nancy, France
        • Recruiting
        • CHU Nancy
        • Contact:
          • Gabrielle ROTH-GUEPI, MD
        • Contact:
          • Jean-Yves NIEMIER, MD
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Paris Saclay - Site de Bicêtre
        • Contact:
          • Laurence LEGROS, MD
        • Contact:
          • Emanuelle DURON, MD
      • Rennes, France
        • Recruiting
        • Chu Rennes
        • Contact:
          • Martine ESCOFFRE-BARBE, MD
      • Saint-Étienne, France
        • Recruiting
        • Chu Saint-Etienne
        • Contact:
          • Philippe RENAUDIER, MD
        • Contact:
          • Blandine DELAVIGERIE, MD
      • Toulouse, France
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse - Oncopole
        • Contact:
          • Francoise huguet, MD
        • Contact:
          • Clément GAUDIN, MD
      • Versailles, France
        • Recruiting
        • CHU Versailles
        • Contact:
          • Philippe ROUSSELOT, Pr

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • CML in chronic phase at time of diagnosis. Diagnosis must be made no more than 3 months (90 days) prior to inclusion. Diagnosis of chronic-phase CML (European Leukemia Network [ELN] 2020 criteria; Baccarani et al 2013) with confirmation of a Philadelphia chromosome (Ph1). A cryptic Ph1 chromosome must be confirmed by FISH.Criteria must meet the definition of chronic phase CML
  • BCR ::ABL1 transcript quantifiable by quantitative PCR
  • 1st-line treatment with tyrosine kinase inhibitor
  • No tyrosine kinase inhibitor or hydroxyurea treatment received prior to first blood sampling (at diagnosis)
  • Signature of informed consent for CML Observatory and signature of informed consent for BIO-TIMER protocol
  • Read and understand French
  • Enrolled in a social security plan or beneficiary of such a plan

Exclusion Criteria:

  • CML in accelerated or blast phase
  • Refusal to participate in the study
  • Treatment started prior to inclusion
  • Patients under guardianship, curatorship, deprivation of liberty or safeguard of justice
  • Pregnant or breast-feeding women

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: All patients
Biological: Blood and bone marrow sample

Individual biological aging determined by DNA methylation analysis will be assessed at D0, M3 and M12.

An optional bone marrow sample will be taken during the myelogram performed at diagnosis.

Individual fragility and quality of life will be assessed using geriatric tools at D0, M6, M12, M24 and M36

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biological age determination
Time Frame: Day 0;Month 3;Month 12
The difference between biological age and chronological age (of the clone and the patient) expressed as a difference and as a percentage.
Day 0;Month 3;Month 12
Individual fragility assessment
Time Frame: Day 0;Month 6;Month 12;Month 24;Month 36
Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities.
Day 0;Month 6;Month 12;Month 24;Month 36
Individual fragility assessment
Time Frame: Day 0;Month 6;Month 12;Month 24;Month 36
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life)
Day 0;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Time Frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance assessed by actual dose received
Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Time Frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance assessed by the number of tyrosine kinase inhibitor discontinuation due to intolerance
Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Time Frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance assessed by a description of adverse events as assessed by CTCAE v5.0
Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Time Frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance assessed by changes and number of tyrosine kinase inhibitor lines
Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance of tyrosine kinase inhibitors
Time Frame: Day 0;Month 3;Month 6;Month 12;Month 24;Month 36
Tolerance assessed by a description of treatment sequences
Day 0;Month 3;Month 6;Month 12;Month 24;Month 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Distribution of individual clinical fragility levels assessed by Geriatric Core Data set at the time of diagnosis.
Time Frame: Day 0
Individual fragility assessed by Geriatric Core Data set assessing social status, independence at home, mobility, nutrition, cognitive status, mood and comorbidities at the time of diagnosis.
Day 0
Distribution of individual clinical fragility levels assessed by Rockwood clinical frailty score at the time of diagnosis.
Time Frame: Day 0
Individual fragility assessed by Rockwood clinical frailty score ranging from 1 (very fit) to 9 (at the end of life) at the time of diagnosis.
Day 0
Evaluation of therapeutic response through quantification of the BCR::ABL transcript
Time Frame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Quantification of BCR::ABL transcript expressed as copy number relative to 100 copies of control gene transcripts
Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Assessment of therapeutic response by quantification of residual disease
Time Frame: Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Decrease in residual disease and achievement of MMR (≤0.1%), MR4 (≤0.01%), MR4.5 (≤0.032%), MR5 (≤0.001%) thresholds)
Month 3;Month 6;Month 12;Month 15;Month 18;Month 21;Month 24;Month 27;Month 30;Month 33;Month 36
Assessment of patients' quality of life
Time Frame: Day 0;Month 6;Month 12;Month 24;Month 36
Quality of life assessed using the European Organisation for Research and Treatment of Cancer LG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients, with a higher score indicating a better health-related quality of life
Day 0;Month 6;Month 12;Month 24;Month 36

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Clermont-Ferrand

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc BERGER, University Hospital, Clermont-Ferrand

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RBHP 2023 BERGER
  • 2023-A00974-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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