Neoplasm MetastasisPERMED01NCT02342158
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors
A study testing biopsy or surgical sampling and blood sampling in people with Neoplasm Metastasis, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- biopsy or surgical sampling and blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2014to 18 Aug 2022
- 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
- Age>18 years
- Histological diagnosis of cancer
- Locally advanced or metastatic, biopsiable disease
- ECOG Performans Status ≤2
- Affiliation to social security
- Signed informed consent.
Who cannot join
- Emergency, Individually deprived of liberty or placed under the authority of a tutor
- Patients with symptomatic or progressive brain metastasis
- Patients who have only bone and/or brain metastases
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003
PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.
- Conditions
- Neoplasm Metastasis
- Being tested
- biopsy or surgical sampling, blood sampling
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy or surgical samplingProcedure or surgery
blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced /metastatic cancer | Experimental | Not described Receives: Procedure: biopsy or surgical sampling; Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
Measured: 4-6 weeks after biopsy
Secondary outcomes (5)
Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing
Measured: 3.5 years
Full exome and transcriptome sequencingof locally advanced and metastatic tumours
Measured: 6 years
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease
Measured: 4 years
Circulating Tumor Cells (CTC) detection and characterization in breast cancer
Comparison of three distinct methods for the CTC detection in blood
Measured: 3.5 years
Preclinical predictive clinical models validation (limited to breast cancer)
Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start12 Nov 2014
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research Center of Marseille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342158
- Sponsor's protocol ID
- PERMED01-IPC 2014-003
- Acronym
- PERMED01
- Status last verified
- Apr 2026
- First submitted
- 16 Dec 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bertucci F, Goncalves A, Guille A, Adelaide J, Garnier S, Carbuccia N, Billon E, Finetti P, Sfumato P, Monneur A, Pecheux C, Khran M, Brunelle S, Mescam L, Thomassin-Piana J, Poizat F, Charafe-Jauffret E, Turrini O, Lambaudie E, Provansal M, Extra JM, Madroszyk A, Gilabert M, Sabatier R, Vicier C, Mamessier E, Chabannon C, Pakradouni J, Viens P, Andre F, Gravis G, Popovici C, Birnbaum D, Chaffanet M. Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial. Genome Med. 2021 May 18;13(1):87. doi: 10.1186/s13073-021-00897-9.
PubMed 34006291Sabatier R, Garnier S, Guille A, Carbuccia N, Pakradouni J, Adelaide J, Provansal M, Cappiello M, Rousseau F, Chaffanet M, Birnbaum D, Mamessier E, Goncalves A, Bertucci F. Whole-genome/exome analysis of circulating tumor DNA and comparison to tumor genomics from patients with heavily pre-treated ovarian cancer: subset analysis of the PERMED-01 trial. Front Oncol. 2022 Jul 29;12:946257. doi: 10.3389/fonc.2022.946257. eCollection 2022.
PubMed 35965534
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003
- ClinicalTrials.gov ID
- NCT02342158
- Acronym / sponsor ID
- PERMED01 / PERMED01-IPC 2014-003
- Conditions
- Neoplasm Metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- Cancer Research Center of Marseille
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 19 Jan 2015 (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.
PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced /metastatic cancer | Experimental | Procedure: biopsy or surgical sampling, Other: blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age>18 years
- Histological diagnosis of cancer
- Locally advanced or metastatic, biopsiable disease
- ECOG Performans Status ≤2
- Affiliation to social security
Key exclusion criteria (4 listed)
- Emergency, Individually deprived of liberty or placed under the authority of a tutor
- Patients with symptomatic or progressive brain metastasis
- Patients who have only bone and/or brain metastases
- Pregnant or breastfeeding women
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 |
|---|---|---|
| biopsy or surgical sampling | Procedure or surgery | Locally advanced /metastatic cancer |
| blood sampling | Other | Locally advanced /metastatic cancer |
Primary outcome
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists
Time frame: 4-6 weeks after biopsy
5 secondary outcomes
Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing
Time frame: 3.5 years
Full exome and transcriptome sequencingof locally advanced and metastatic tumours
Time frame: 6 years
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease
Time frame: 4 years
Circulating Tumor Cells (CTC) detection and characterization in breast cancer
Time frame: 3.5 years
Preclinical predictive clinical models validation (limited to breast cancer)
Time frame: 4 years
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 21 Apr 2026.
- Results publication: PubMed 34006291Bertucci F, Goncalves A, Guille A, Adelaide J, Garnier S, Carbuccia N, Billon E, Finetti P, Sfumato P, Monneur A, Pecheux C, Khran M, Brunelle S, Mescam L, Thomassin-Piana J, Poizat F, Charafe-Jauffret E, Turrini O, Lambaudie E, Provansal M, Extra JM, Madroszyk A, Gilabert M, Sabatier R, Vicier C, Mamessier E, Chabannon C, Pakradouni J, Viens P, Andre F, Gravis G, Popovici C, Birnbaum D, Chaffanet M. Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial. Genome Med. 2021 May 18;13(1):87. doi: 10.1186/s13073-021-00897-9.
- Results publication: PubMed 35965534Sabatier R, Garnier S, Guille A, Carbuccia N, Pakradouni J, Adelaide J, Provansal M, Cappiello M, Rousseau F, Chaffanet M, Birnbaum D, Mamessier E, Goncalves A, Bertucci F. Whole-genome/exome analysis of circulating tumor DNA and comparison to tumor genomics from patients with heavily pre-treated ovarian cancer: subset analysis of the PERMED-01 trial. Front Oncol. 2022 Jul 29;12:946257. doi: 10.3389/fonc.2022.946257. eCollection 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy or surgical sampling and blood sampling in people with Neoplasm Metastasis, run by Institut Paoli-Calmettes at 1 site 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 6 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: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists (time frame: 4-6 weeks after biopsy). 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 NCT02342158, which also lists 2 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 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.