Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET) (PLANET)

June 30, 2022 updated by: Centre Leon Berard

A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies

The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Most of the molecular screening programs have allowed to successfully guide patients to personalized therapy only for a minority of patients (10-20%) and few patients have actually benefit from these programs with low objective response under personalized therapy.

During the course of disease and / or of treatment, tumors become more heterogeneous and include a collection of cells harboring distinct molecular signatures with differential levels of sensitivity to treatment. Assessment of tumor heterogeneity and plasticity are essential for the development of effective therapies. Longitudinal analysis of biopsy samples is of considerable interest to assess the complex clonal architecture of cancers and potentially adapt cancer treatment to tumor profile/characteristics overtime. In this context, profiling of circulating tumor DNA using non-invasive liquid biopsies is also an interesting approach to assess cancer evolution by showing the contribution of clonal heterogeneity to chemotherapy resistance and metastasis in high-risk patients.

The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • 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 Locations

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

I1. Adult male or female patient with confirmed diagnosis of advanced/metastatic cancer to be treated with standard anti-cancer treatment according to :

  • For metastatic Small cell lung cancer (SLCC) : treatment by Immunotherapy ± chemotherapy
  • For Recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC) : treatment by Immunotherapy (all lines) ± chemotherapy if in agreement with SmPC
  • For Metastatic Urothelial carcinoma : treatment by 1st line chemotherapy with avelumab as maintenance treatment (patients will be enrolled following 4 to 6 cycles of CT, only patient initiating avelumab maintenance are eligible (i.e. patients with SD or PR after CT)
  • For MSI-High, any tumor types : treatment by Immunotherapy
  • For HPV-related cancers, any tumor types : treatment by Immunotherapy
  • Metastatic GIST : treatment by Imatinib
  • BRAF- V600E tumors (lung and thyroid cancer) : treatment by Dabrafenib + trametinib
  • BRAF- mutated tumors (CRC, lung and thyroid cancer) :

Lung (V600E only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib): treatment by Dabrafenib + trametinib CRC (BRAF V600E): treatment by Encorafenib + cetuximab

  • All solid tumor types with ret fusion / mutation : treatment by Selpercatinib
  • Metastatic Triple negative breast cancer (TNBC) : treatment by 1st line chemotherapy
  • Glioblastoma : treatment by Radiochemotherapy
  • Advanced high grade epithelial ovarian cancer : treatment by 1st line Chemotherapy
  • Chronic Lymphocytic Leukemia (CLL) in the relapsed setting : treatment by Bruton Kinase Inhibitors

I2. All solid tumor cohorts: Availability of an archival representative formalin-fixed paraffin-embedded (FFPE) tumor sample [...]

I3. All solid tumor cohorts: Disease evaluable as per RECIST V1.1

I4. All solid tumor cohorts excluding Glioblastoma: Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic mandatory de novo tumor sampling [...]

I5. Performance status (PS) ECOG 0 or 1.

I6. Patient should understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures including sequential tumor biopsies as per protocol.

I7. Patient must be covered by a medical insurance.

Exclusion Criteria:

NI1. All solid tumor cohorts - Patient with non-acceptable tumor sample at screening.

NI2. Any condition contraindicated with blood/tumor sampling procedures required by the protocol.

NI3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.

NI4. Pregnant or breast-feeding woman.

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMMUNOTHERAPY COHORTS
This cohort include following cancers treated with immunotherapy : metastatic Small cell lung cancer (SLCC); recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC); MSI-High, any tumor types and HPV-related cancers,any tumor types
Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.
Experimental: TARGETED THERAPIES COHORTS
This cohort include following cancers treated with targeted therapies : Metastatic GIST; BRAF-mutated tumors (CRC (BRAF V600E), lung (V600 only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib) cancer); All solid tumor types with RET fusion / mutation and Chronic Lymphocytic Leukemia (CLL) in the relapsed setting.
Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.
Experimental: CHEMOTHERAPY COHORTS
This cohort include following cancers treated with chemotherapies : metastatic Small cell lung cancer (SLCC); recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC); Metastatic Triple negative breast cancer (TNBC); Glioblastoma; Advanced high grade epithelial ovarian cancer
Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with meaningful molecular genetic alterations on tumor sample
Time Frame: At the end of study (4 years)
Identification of molecular genetic alterations based on molecular characterisation (WES and RNASeq) of tumor at diagnosis, then under standard anti-cancer treatment : treatment start, 1st radiological evaluation and disease progression
At the end of study (4 years)
Number of patients with meaningful molecular genetic alterations on circulating tumour DNA (ctDNA)
Time Frame: At the end of study (4 years)
Identification of molecular genetic alterations based on molecular characterisation (WES and RNASeq) of ctDNA under standard anti-cancer treatment : treatment start, each radiological evaluation and disease progression
At the end of study (4 years)
Number of patients with meaningful immunological features
Time Frame: At the end of study (4 years)
Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment
At the end of study (4 years)
Objective Response Rate (ORR) as per RECIST V1.1 and according to central review
Time Frame: 3 months
For solid tumors excluding glioblastoma only
3 months
Progression-Free Survival (PFS)
Time Frame: 6 months
For glioblastoma only
6 months
Objective Response Rate (ORR) according to iwCLL criteria
Time Frame: 6 months
For chronic lymphocytic leukemia
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between disease evolution and molecular and/or immunological biomarkers
Time Frame: Time Frame: up to 4 years
To identify potential prognostic and predictive biomarkers on tumor samples collected during patient's treatment and follow-up detected by molecular biology techniques, and on immunological findings
Time Frame: up to 4 years
Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample.
Time Frame: 48 months
To identify potential prognostic and predictive biomarkers based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques
48 months
Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)
Time Frame: 48 months
48 months
Tumor characteristics using a radiomic approach and detailed analyses of imaging.
Time Frame: 48 months
48 months
FACT-G questionnaire
Time Frame: 48 months
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
48 months
HADS questionnaire
Time Frame: 48 months
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
48 months
PRO questionnaire
Time Frame: 48 months
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
48 months
Correlation between patient's understanding and experiences of precision medicine clinical trial
Time Frame: 48 months
Measured by thematic analysis of semi-structured interviews: themes and sub-themes will be analyzed in order to develop items for the construction and validation of a quantitative questionnaire.
48 months
Correlation between socio-spatial inequalities in access to the PLANET program and the impact on the quality of life of patients
Time Frame: 48 months
Questionnaire
48 months
TKI pharmacokinetics
Time Frame: 48 months
Plasma concentrations of TKI
48 months

Collaborators and Investigators

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

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Pierre SAINTIGNY, MD, PhD, Centre léon bérard

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)

November 16, 2021

Primary Completion (Anticipated)

September 15, 2025

Study Completion (Anticipated)

September 15, 2025

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

October 18, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Plasticity Longitudinal cANcer

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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