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NCT Number: NCT02342158

Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

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.

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Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Paoli-Calmettes

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biopsy or surgical sampling

Procedure

Blood sampling

Other

Primary outcomes

  1. proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists

    Time frame: 4-6 weeks after biopsy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • Cancer Research Center of Marseille

Registry information

Official study title

Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003

Acronym: PERMED01

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jan 19, 2015
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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