Advanced / Metastic Solid TumorsPLANETNCT05099068
Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)
A study testing Blood and tumor samples in people with Advanced / Metastic Solid Tumors and Glioblastoma, run by Centre Leon Berard at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced / Metastic Solid Tumors, Glioblastoma, Chronic Leukemia Lymphocytic
- What is being tested?
- Blood and tumor samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Nov 2021to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
HOPITAL Pierre WERTHEIMER - HCL
Bron, 69677
François DUCRAY, MD, 04 72 68 13 21, francois.ducray@chu-lyon.fr
- Recruiting
Centre Léon Bérard
Lyon, 69373
Pierre SAINTIGNY, MD,PhD, 04 69 85 60 05, pierre.saintigny@lyon.unicancer.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- Blood and tumor samples
- Keywords
- Molecular Screening, Genomic profiles, Transcriptomic profiles
- Medical subject headings
- Glioblastoma, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and tumor samplesBiological
Longitudinal molecular profiling of tumor and liquid biopsies.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Biological: Blood and tumor samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Progression-Free Survival (PFS)
For glioblastoma only
Measured: 6 months
Objective Response Rate (ORR) according to iwCLL criteria
For chronic lymphocytic leukemia
Measured: 6 months
Secondary outcomes (10)
Correlation between disease evolution and molecular and/or immunological biomarkers
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
Measured: Time Frame: up to 4 years
Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample.
To identify potential prognostic and predictive biomarkers based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques
Measured: 48 months
Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)
Measured: 48 months
Tumor characteristics using a radiomic approach and detailed analyses of imaging.
Measured: 48 months
FACT-G questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Measured: 48 months
HADS questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Measured: 48 months
PRO questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Measured: 48 months
Correlation between patient's understanding and experiences of precision medicine clinical trial
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.
Measured: 48 months
Correlation between socio-spatial inequalities in access to the PLANET program and the impact on the quality of life of patients
Questionnaire
Measured: 48 months
TKI pharmacokinetics
Plasma concentrations of TKI
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start16 Nov 2021
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced / Metastic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre SAINTIGNY, MD, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099068
- Sponsor's protocol ID
- Plasticity Longitudinal cANcer
- Acronym
- PLANET
- Status last verified
- Jun 2022
- First submitted
- 30 Jul 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies
- ClinicalTrials.gov ID
- NCT05099068
- Acronym / sponsor ID
- PLANET / Plasticity Longitudinal cANcer
- Keywords
- Molecular Screening, Genomic profiles, Transcriptomic profiles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMMUNOTHERAPY COHORTS | Experimental | Biological: Blood and tumor samplesThis 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 |
| TARGETED THERAPIES COHORTS | Experimental | Biological: Blood and tumor samplesThis 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. |
| CHEMOTHERAPY COHORTS | Experimental | Biological: Blood and tumor samplesThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and tumor samplesLongitudinal molecular profiling of tumor and liquid biopsies. | Biological | CHEMOTHERAPY COHORTS, IMMUNOTHERAPY COHORTS, TARGETED THERAPIES COHORTS |
Primary outcome
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
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
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
Objective Response Rate (ORR) as per RECIST V1.1 and according to central review
Time frame: 3 months
For solid tumors excluding glioblastoma only
Progression-Free Survival (PFS)
Time frame: 6 months
For glioblastoma only
Objective Response Rate (ORR) according to iwCLL criteria
Time frame: 6 months
For chronic lymphocytic leukemia
10 secondary outcomes
Correlation between disease evolution and molecular and/or immunological biomarkers
Time frame: 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
Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)
Time frame: 48 months
Tumor characteristics using a radiomic approach and detailed analyses of imaging.
Time frame: 48 months
FACT-G questionnaire
Time frame: 48 months
HADS questionnaire
Time frame: 48 months
PRO questionnaire
Time frame: 48 months
Correlation between patient's understanding and experiences of precision medicine clinical trial
Time frame: 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
TKI pharmacokinetics
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre SAINTIGNY, MD, PhD principal investigator
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and tumor samples in people with Advanced / Metastic Solid Tumors and Glioblastoma, run by Centre Leon Berard at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre SAINTIGNY, MD, PhD (04 69 85 60 05, Pierre.saintigny@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with meaningful molecular genetic alterations on tumor sample (time frame: At the end of study (4 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.