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Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors (PERMED01)

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ClinicalTrials.gov Identifier: NCT02342158
Recruitment Status : Active, not recruiting
First Posted : January 19, 2015
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Cancer Research Center of Marseille
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Procedure: biopsy or surgical sampling Other: blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003
Actual Study Start Date : November 12, 2014
Actual Primary Completion Date : June 2020
Estimated Study Completion Date : November 2022

Arm Intervention/treatment
Experimental: Locally advanced /metastatic cancer Procedure: biopsy or surgical sampling
Other: blood sampling



Primary Outcome Measures :
  1. proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists [ Time Frame: 4-6 weeks after biopsy ]

Secondary Outcome Measures :
  1. Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing [ Time Frame: 3.5 years ]
  2. Full exome and transcriptome sequencingof locally advanced and metastatic tumours [ Time Frame: 6 years ]
  3. Circulating tumor DNA detection and characterization in locally advanced and metastatic disease [ Time Frame: 4 years ]
  4. Circulating Tumor Cells (CTC) detection and characterization in breast cancer [ Time Frame: 3.5 years ]
    Comparison of three distinct methods for the CTC detection in blood

  5. Preclinical predictive clinical models validation (limited to breast cancer) [ Time Frame: 4 years ]
    Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18 years
  • Histological diagnosis of cancer
  • Locally advanced or metastatic, biopsiable disease
  • ECOG Performans Status ≤2
  • Affiliation to social security
  • Signed informed consent.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342158


Locations
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France
Institut Paoli-Calmettes
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Cancer Research Center of Marseille
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT02342158    
Other Study ID Numbers: PERMED01-IPC 2014-003
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes