CancerALCINANCT02866149
Analysis of Circulating Tumor Markers in the Blood (ALCINA)
A study testing Blood sampling, Tumor sampling and Stool sampling in people with Cancer, run by Institut Curie at 5 sites in France.
Trial summary
Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood sampling, Tumor sampling and Stool sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 5 sitesFrance
- Study dates
- Jul 2015to Sep 2024
- 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
- Patient with any tumoral disease (proven or suspected), of any type and stage
- More than18 years old
- Signed informed consent form
- Additional inclusion criteria if a tumor sample is needed:
- Tumor considered as accessible by biopsy
- Normal blood coagulation tests on the last blood analysis
Show all 12Show fewer
- Non-inclusion Criteria:
- Patient in detention or protected by the law
- Patient who cannot comply with the study follow up for geographical, social or psychological reasons
- Additional non-inclusion criteria if a tumor sample is needed:
- Anticoagulant or antiaggregant that cannot be interrupted for the biopsy
- central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Georges François Leclerc
Dijon, 21079
Institut du Cancer de Montpellier
Montpellier, 34298
Institut Curie (Paris hospital)
Paris, 75005
Institut Mutualiste Montsouris
Paris, 75014
Institut Curie (St Cloud hospital)
Saint-Cloud, 92210
About this study
Official title: Analysis of Circulating Tumor Markers in the Blood
Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.
Read the detailed description
Exploratory multi-cohort study including different types of cancer (different organs and/or different histological types).
Each kind of blood-borne biological markers analyses corresponds to a cohort.
- Conditions
- Cancer
- Being tested
- Blood sampling, Tumor sampling, Stool sampling
- Keywords
- Cancer, circulating tumor biomarkers, circulating tumor DNA, Circulating tumor Cell (CTC)
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Up to 5 blood samplings can be performed at different time points
Tumor samplingProcedure or surgery
One tumor sampling can be performed, if applicable
Stool samplingOther
Up to 5 blood samplings can be performed at different time points
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - "Anti checkpoint" | Other | Monitoring of patients with tumours treated by immune therapy.
Timing of blood sampling:
* inclusion
* after #8 weeks on therapy
* at progression or 6 months from inclusion for patient without progressive disease
* if toxicity grade 3 or 4, or grade 2 until 1 month. Receives: Biological: Blood sampling |
| Cohort 2 - "Oncoscan®" | Other | Monitoring of patients with HER 2+/- breast cancer and correlation with genome-wide copy number, loss of heterozygosity detection, as well as identification of frequently tested somatic mutations (Oncoscan® assays).
Timing of blood sampling:
* inclusion
* after 1 cycle of therapy (weeks 3-4)
* up to 2 other samples, timepoints decided by the investigator Receives: Biological: Blood sampling |
| Cohort 3 - "CirCe-PLA" | Experimental | Feasibility of Proximity-Ligation Assay (PLA) to study membrane proteins dimerisation by on isolated tumour cells in patients with HER2+/- breast cancer (HER 2+/-).
One tumor sampling.
Timing of blood sampling:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator. Receives: Biological: Blood sampling; Procedure: Tumor sampling |
| Cohort 4 - "CDX PDX" | Other | Establishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling.
One tumor sampling.
Timing of blood sampling:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator. Receives: Biological: Blood sampling; Procedure: Tumor sampling |
| Cohort 5 - "Post-TP53" | Other | Follow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer.
Timing of blood sampling:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator. Receives: Biological: Blood sampling |
| Cohort 6 - "Palbociclib" | Other | Monitoring of patients treated with palbociclib
Timing of blood sampling:
* Inclusion day (2 samples)
* after #2 weeks of therapy
* after #4 weeks of therapy
* at progression. Receives: Biological: Blood sampling |
| Cohort 7 - "CTC_PD-L1_Breast" | Other | Detection of PD-L1 in metastatic breast cancer patients
Timing of blood sampling:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator. Receives: Biological: Blood sampling |
| Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary" | Other | Detection of PD-L1 in metastatic lung cancer patients
Timing of blood sampling:
* Inclusion
* up to 3 other samples, timepoints decided by the investigator. Receives: Biological: Blood sampling |
| Cohort 9 - "NSCLC" | Other | Monitoring of patients with Non-Small Cell lung Cancer treated by immune therapy.
Blood sampling at 4 timepoints. Receives: Biological: Blood sampling; Procedure: Tumor sampling; Other: Stool sampling |
| Cohort 10 - "Palbociclib II" | Other | Monitoring of patient with a metastatic breast cancer treated by palbociclib.
Timing of blood sampling:
* Inclusion
* after #4 weeks of therapy
* at the first tumoral evaluation (month 3 or 4)
* at progression. Receives: Biological: Blood sampling |
| Cohort 11 - Sarcomas | Other | The cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging. Receives: Biological: Blood sampling |
| Cohort 12 - Faslorad | Other | Monitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor.
Timing of blood sampling:
* Inclusion
* after #3-5 weeks of therapy
* at the first tumoral evaluation (month 2 or 3)
* at progression. Receives: Biological: Blood sampling |
| Cohort 13 - MUm | Other | The cohort concerns patients with uveal melanoma in the 1st systemic line at the metastatic stage (may have had prior adjuvant therapy or surgery/radiofrequency).
Timing of blood sampling:
* J1C1
* J2C1
* J1C2
* J1C5 (first tumoral evaluation). Receives: Biological: Blood sampling |
| Cohort 14 - CNBC Snipe | Other | This cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1.
One tumour sampling.
Timing of blood sampling:
* before treatment
* at W8 of treatment (after radiological examination)
* at W12 of treatment
* at progression or 18 months after the beginning of treatment Receives: Biological: Blood sampling; Procedure: Tumor sampling |
| Cohort 15 - Breast CLI | Other | This cohort concerns patients with metastatic lobular breast cancer One tumour sampling.
Timing of blood sampling:
* At inclusion
* After biopsy post inclusion (or in 15 days after)
* after 1 or 2 months of treatment
* at progression or 18 months after inclusion Receives: Biological: Blood sampling; Procedure: Tumor sampling |
| Cohort 16 - Mum immunothérapie | Other | This cohort concerns patients with metastatic uveal melanoma before immunotherapy treatment.
Timing of blood sampling :
* at inclusion
* at cycle 2 or 3 of treatment
* at the first tumoral evaluation (C5D1)
* at progression Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the analysis of different blood-borne tumor biomarkers
Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients ".
Measured: 18 months
Secondary outcomes (1)
Correlation with biological and clinical data
Number of biological analysis results correlated to clinical data. Establishment of a proof of concept
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2024
- Study completionSep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Clément BIDARD, MD PhD, Study director, Institut Curie, Paris (FR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866149
- Sponsor's protocol ID
- IC 2015-02
- Acronym
- ALCINA
- Status last verified
- Sep 2024
- First submitted
- 28 Jul 2016
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Rampanou A, Rodrigues M, Bidard FC, Cassoux N, Matet A, Vincent-Salomon A, Jeannot E, Bieche I, Roman-Roman S, Stern MH, Renault S. Circulating Tumor DNA Monitoring in Patients with Uveal Melanoma Using Mutation-Agnostic Multiplex Drop-Off ddPCR Assays. Anal Chem. 2026 May 19;98(19):14260-14269. doi: 10.1021/acs.analchem.6c00476. Epub 2026 May 4.
PubMed 42082165Rodrigues M, Ramtohul T, Rampanou A, Sandoval JL, Houy A, Servois V, Mailly-Giacchetti L, Pierron G, Vincent-Salomon A, Cassoux N, Mariani P, Dutriaux C, Pracht M, Ryckewaert T, Kurtz JE, Roman-Roman S, Piperno-Neumann S, Bidard FC, Stern MH, Renault S. Prospective assessment of circulating tumor DNA in patients with metastatic uveal melanoma treated with tebentafusp. Nat Commun. 2024 Oct 14;15(1):8851. doi: 10.1038/s41467-024-53145-0.
PubMed 39402032Eslami-S Z, Cortes-Hernandez LE, Sinoquet L, Gauthier L, Vautrot V, Cayrefourcq L, Avoscan L, Jacot W, Pouderoux S, Viala M, Thomas QD, Lamy PJ, Quantin X, Gobbo J, Alix-Panabieres C. Circulating tumour cells and PD-L1-positive small extracellular vesicles: the liquid biopsy combination for prognostic information in patients with metastatic non-small cell lung cancer. Br J Cancer. 2024 Jan;130(1):63-72. doi: 10.1038/s41416-023-02491-9. Epub 2023 Nov 16.
PubMed 37973956Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabieres C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131.
PubMed 34355741Darrigues L, Pierga JY, Bernard-Tessier A, Bieche I, Silveira AB, Michel M, Loirat D, Cottu P, Cabel L, Dubot C, Geiss R, Ricci F, Vincent-Salomon A, Proudhon C, Bidard FC. Circulating tumor DNA as a dynamic biomarker of response to palbociclib and fulvestrant in metastatic breast cancer patients. Breast Cancer Res. 2021 Mar 6;23(1):31. doi: 10.1186/s13058-021-01411-0.
PubMed 33676547Cabel L, Rosenblum D, Lerebours F, Brain E, Loirat D, Bergqvist M, Cottu P, Donnadieu A, Bethune A, Kiavue N, Rodrigues M, Pierga JY, Tanguy ML, Bidard FC. Plasma thymidine kinase 1 activity and outcome of ER+ HER2- metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast Cancer Res. 2020 Sep 14;22(1):98. doi: 10.1186/s13058-020-01334-2.
PubMed 32928264Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabieres C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121.
PubMed 32712650
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Circulating Tumor Markers in the Blood
- ClinicalTrials.gov ID
- NCT02866149
- Acronym / sponsor ID
- ALCINA / IC 2015-02
- Conditions
- Cancer
- Keywords
- Cancer, circulating tumor biomarkers, circulating tumor DNA, Circulating tumor Cell (CTC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jul 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 15 Aug 2016 (estimated)
- 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.
Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.
Detailed description
Exploratory multi-cohort study including different types of cancer (different organs and/or different histological types).
Each kind of blood-borne biological markers analyses corresponds to a cohort.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - "Anti checkpoint" | Other | Biological: Blood samplingMonitoring of patients with tumours treated by immune therapy. Timing of blood sampling: * inclusion * after #8 weeks on therapy * at progression or 6 months from inclusion for patient without progressive disease * if toxicity grade 3 or 4, or grade 2 until 1 month. |
| Cohort 2 - "Oncoscan®" | Other | Biological: Blood samplingMonitoring of patients with HER 2+/- breast cancer and correlation with genome-wide copy number, loss of heterozygosity detection, as well as identification of frequently tested somatic mutations (Oncoscan® assays). Timing of blood sampling: * inclusion * after 1 cycle of therapy (weeks 3-4) * up to 2 other samples, timepoints decided by the investigator |
| Cohort 3 - "CirCe-PLA" | Experimental | Biological: Blood sampling, Procedure: Tumor samplingFeasibility of Proximity-Ligation Assay (PLA) to study membrane proteins dimerisation by on isolated tumour cells in patients with HER2+/- breast cancer (HER 2+/-). One tumor sampling. Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. |
| Cohort 4 - "CDX PDX" | Other | Biological: Blood sampling, Procedure: Tumor samplingEstablishment of xenografts from tumor (PDX) and from Circulating Tumour Cell (CDX) by tumour and blood sampling. One tumor sampling. Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. |
| Cohort 5 - "Post-TP53" | Other | Biological: Blood samplingFollow-up of patients previously treated by neoadjuvant chemotherapy for triple negative breast cancer. Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. |
| Cohort 6 - "Palbociclib" | Other | Biological: Blood samplingMonitoring of patients treated with palbociclib Timing of blood sampling: * Inclusion day (2 samples) * after #2 weeks of therapy * after #4 weeks of therapy * at progression. |
| Cohort 7 - "CTC_PD-L1_Breast" | Other | Biological: Blood samplingDetection of PD-L1 in metastatic breast cancer patients Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. |
| Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary" | Other | Biological: Blood samplingDetection of PD-L1 in metastatic lung cancer patients Timing of blood sampling: * Inclusion * up to 3 other samples, timepoints decided by the investigator. |
| Cohort 9 - "NSCLC" | Other | Biological: Blood sampling, Procedure: Tumor sampling, Other: Stool samplingMonitoring of patients with Non-Small Cell lung Cancer treated by immune therapy. Blood sampling at 4 timepoints. |
| Cohort 10 - "Palbociclib II" | Other | Biological: Blood samplingMonitoring of patient with a metastatic breast cancer treated by palbociclib. Timing of blood sampling: * Inclusion * after #4 weeks of therapy * at the first tumoral evaluation (month 3 or 4) * at progression. |
| Cohort 11 - Sarcomas | Other | Biological: Blood samplingThe cohort includes all patients with bone or soft tissue sarcoma. Timing of blood sampling depending on disease staging. |
| Cohort 12 - Faslorad | Other | Biological: Blood samplingMonitoring of patient with a metastatic breast cancer initiating a treatment by Faslodex-Afinitor. Timing of blood sampling: * Inclusion * after #3-5 weeks of therapy * at the first tumoral evaluation (month 2 or 3) * at progression. |
| Cohort 13 - MUm | Other | Biological: Blood samplingThe cohort concerns patients with uveal melanoma in the 1st systemic line at the metastatic stage (may have had prior adjuvant therapy or surgery/radiofrequency). Timing of blood sampling: * J1C1 * J2C1 * J1C2 * J1C5 (first tumoral evaluation). |
| Cohort 14 - CNBC Snipe | Other | Biological: Blood sampling, Procedure: Tumor samplingThis cohort concerns patients with metastatic Non-Small Cell lung Cancer receiving anti-PD-1/PD-L1. One tumour sampling. Timing of blood sampling: * before treatment * at W8 of treatment (after radiological examination) * at W12 of treatment * at progression or 18 months after the beginning of treatment |
| Cohort 15 - Breast CLI | Other | Biological: Blood sampling, Procedure: Tumor samplingThis cohort concerns patients with metastatic lobular breast cancer One tumour sampling. Timing of blood sampling: * At inclusion * After biopsy post inclusion (or in 15 days after) * after 1 or 2 months of treatment * at progression or 18 months after inclusion |
| Cohort 16 - Mum immunothérapie | Other | Biological: Blood samplingThis cohort concerns patients with metastatic uveal melanoma before immunotherapy treatment. Timing of blood sampling : * at inclusion * at cycle 2 or 3 of treatment * at the first tumoral evaluation (C5D1) * at progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with any tumoral disease (proven or suspected), of any type and stage
- More than18 years old
- Signed informed consent form
- Tumor considered as accessible by biopsy
- Normal blood coagulation tests on the last blood analysis
Key exclusion criteria (0 listed)
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 samplingUp to 5 blood samplings can be performed at different time points | Biological | Cohort 1 - "Anti checkpoint", Cohort 10 - "Palbociclib II", Cohort 11 - Sarcomas, Cohort 12 - Faslorad, Cohort 13 - MUm, Cohort 14 - CNBC Snipe, Cohort 15 - Breast CLI, Cohort 16 - Mum immunothérapie, Cohort 2 - "Oncoscan®", Cohort 3 - "CirCe-PLA", Cohort 4 - "CDX PDX", Cohort 5 - "Post-TP53", Cohort 6 - "Palbociclib", Cohort 7 - "CTC_PD-L1_Breast", Cohort 8 - "CTC_PD-L1_Broncho-Pulmonary", Cohort 9 - "NSCLC" |
| Tumor samplingOne tumor sampling can be performed, if applicable | Procedure or surgery | Cohort 14 - CNBC Snipe, Cohort 15 - Breast CLI, Cohort 3 - "CirCe-PLA", Cohort 4 - "CDX PDX", Cohort 9 - "NSCLC" |
| Stool samplingUp to 5 blood samplings can be performed at different time points | Other | Cohort 9 - "NSCLC" |
Primary outcome
Feasibility of the analysis of different blood-borne tumor biomarkers
Time frame: 18 months
Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio " detection success " / " number of screened patients ".
1 secondary outcome
Correlation with biological and clinical data
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 42082165Rampanou A, Rodrigues M, Bidard FC, Cassoux N, Matet A, Vincent-Salomon A, Jeannot E, Bieche I, Roman-Roman S, Stern MH, Renault S. Circulating Tumor DNA Monitoring in Patients with Uveal Melanoma Using Mutation-Agnostic Multiplex Drop-Off ddPCR Assays. Anal Chem. 2026 May 19;98(19):14260-14269. doi: 10.1021/acs.analchem.6c00476. Epub 2026 May 4.
- Derived from this study: PubMed 39402032Rodrigues M, Ramtohul T, Rampanou A, Sandoval JL, Houy A, Servois V, Mailly-Giacchetti L, Pierron G, Vincent-Salomon A, Cassoux N, Mariani P, Dutriaux C, Pracht M, Ryckewaert T, Kurtz JE, Roman-Roman S, Piperno-Neumann S, Bidard FC, Stern MH, Renault S. Prospective assessment of circulating tumor DNA in patients with metastatic uveal melanoma treated with tebentafusp. Nat Commun. 2024 Oct 14;15(1):8851. doi: 10.1038/s41467-024-53145-0.
- Derived from this study: PubMed 37973956Eslami-S Z, Cortes-Hernandez LE, Sinoquet L, Gauthier L, Vautrot V, Cayrefourcq L, Avoscan L, Jacot W, Pouderoux S, Viala M, Thomas QD, Lamy PJ, Quantin X, Gobbo J, Alix-Panabieres C. Circulating tumour cells and PD-L1-positive small extracellular vesicles: the liquid biopsy combination for prognostic information in patients with metastatic non-small cell lung cancer. Br J Cancer. 2024 Jan;130(1):63-72. doi: 10.1038/s41416-023-02491-9. Epub 2023 Nov 16.
- Derived from this study: PubMed 34355741Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabieres C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131.
- Derived from this study: PubMed 33676547Darrigues L, Pierga JY, Bernard-Tessier A, Bieche I, Silveira AB, Michel M, Loirat D, Cottu P, Cabel L, Dubot C, Geiss R, Ricci F, Vincent-Salomon A, Proudhon C, Bidard FC. Circulating tumor DNA as a dynamic biomarker of response to palbociclib and fulvestrant in metastatic breast cancer patients. Breast Cancer Res. 2021 Mar 6;23(1):31. doi: 10.1186/s13058-021-01411-0.
- Derived from this study: PubMed 32928264Cabel L, Rosenblum D, Lerebours F, Brain E, Loirat D, Bergqvist M, Cottu P, Donnadieu A, Bethune A, Kiavue N, Rodrigues M, Pierga JY, Tanguy ML, Bidard FC. Plasma thymidine kinase 1 activity and outcome of ER+ HER2- metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast Cancer Res. 2020 Sep 14;22(1):98. doi: 10.1186/s13058-020-01334-2.
- Derived from this study: PubMed 32712650Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabieres C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
François-Clément BIDARD, MD PhD study director
Institut Curie, Paris (FR)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Tumor sampling and Stool sampling in people with Cancer, run by Institut Curie at 5 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 12 inclusion and 0 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: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the analysis of different blood-borne tumor biomarkers (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02866149, which also lists 7 linked publications.
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 1 Oct 2024.