NCT05099068

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

3.8 years

First QC Date

July 30, 2021

Last Update Submit

June 30, 2022

Conditions

Advanced / Metastic Solid TumorsGlioblastomaChronic Leukemia Lymphocytic

Keywords

Molecular ScreeningGenomic profilesTranscriptomic profiles

Outcome Measures

Primary Outcomes (6)

  • Number of patients with meaningful molecular genetic alterations on tumor sample

    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)

    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

    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

    For solid tumors excluding glioblastoma only

    3 months

  • Progression-Free Survival (PFS)

    For glioblastoma only

    6 months

  • Objective Response Rate (ORR) according to iwCLL criteria

    For chronic lymphocytic leukemia

    6 months

Secondary Outcomes (10)

  • Correlation between disease evolution and molecular and/or immunological biomarkers

    Time Frame: up to 4 years

  • Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample.

    48 months

  • Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)

    48 months

  • Tumor characteristics using a radiomic approach and detailed analyses of imaging.

    48 months

  • FACT-G questionnaire

    48 months

  • +5 more secondary outcomes

Study Arms (3)

IMMUNOTHERAPY COHORTS

EXPERIMENTAL

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

TARGETED THERAPIES COHORTS

EXPERIMENTAL

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

CHEMOTHERAPY COHORTS

EXPERIMENTAL

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

Interventions

Blood and tumor samplesBIOLOGICAL

Longitudinal molecular profiling of tumor and liquid biopsies.

CHEMOTHERAPY COHORTSIMMUNOTHERAPY COHORTSTARGETED THERAPIES COHORTS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HOPITAL Pierre WERTHEIMER - HCL

Bron, 69677, France

NOT YET RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

MeSH Terms

Conditions

GlioblastomaLeukemia, B-Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueLeukemia, LymphoidLeukemiaHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre SAINTIGNY, MD, PhD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre SAINTIGNY, MD, PhD

CONTACT

04 69 85 60 05Pierre.saintigny@lyon.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

October 29, 2021

Study Start

November 16, 2021

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

FR(2)