Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET) (PLANET)
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ClinicalTrials.gov Identifier: NCT05099068 |
Recruitment Status :
Recruiting
First Posted : October 29, 2021
Last Update Posted : July 5, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | July 30, 2021 | ||||
First Posted Date ICMJE | October 29, 2021 | ||||
Last Update Posted Date | July 5, 2022 | ||||
Actual Study Start Date ICMJE | November 16, 2021 | ||||
Estimated Primary Completion Date | September 15, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET) | ||||
Official Title ICMJE | A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies | ||||
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. | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
500 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 15, 2025 | ||||
Estimated Primary Completion Date | September 15, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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 :
Lung (V600E only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib): treatment by Dabrafenib + trametinib CRC (BRAF V600E): treatment by Encorafenib + cetuximab
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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05099068 | ||||
Other Study ID Numbers ICMJE | Plasticity Longitudinal cANcer | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Centre Leon Berard | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Centre Leon Berard | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Centre Leon Berard | ||||
Verification Date | June 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |