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Trial record 3 of 175 for:    Breast Cancer | Marseille, France

Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy (NEO-R)

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ClinicalTrials.gov Identifier: NCT04504747
Recruitment Status : Not yet recruiting
First Posted : August 7, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
The present project aims at identifying robust candidates for drug resistance in BC patients eligible for NAC. Its originality lies upon the combination of three different and complementary prospective approaches: from the molecular analyses of biopsies sampled before and after NAC, from in vitro BC Patient-Derived Organoids (PDO) mimicking patient's response to NAC, and from Circulating Tumor Cells (CTCs) isolated before/during/after NAC.

Condition or disease Intervention/treatment
Breast Cancer Female Other: molecular analysis of blood and tumor

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Time Molecular Analysis of Breast Cancer Receiving Neo-adjuvant Chemotherapy: Identification of Preclinical Models Predictive for Therapeutic Resistance
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
RH+
Prospective blood and biopsie analyses
Other: molecular analysis of blood and tumor
RNAseq, DNAseq, CTCs

HER2+
Prospective blood and biopsie analyses
Other: molecular analysis of blood and tumor
RNAseq, DNAseq, CTCs

TN
Prospective blood and biopsie analyses
Other: molecular analysis of blood and tumor
RNAseq, DNAseq, CTCs




Primary Outcome Measures :
  1. Identify robust candidates - "innate, "acquired stable" and/or reversible" [ Time Frame: 5 years ]
    comparison of pre and/or post NAC molecular profiles in tumors, PDO models and CTCs - will be targeted with a drug in relevant models


Secondary Outcome Measures :
  1. public repertoire of whole transcriptome and targeted-NGS [ Time Frame: 5 years ]
    NAC" database will be constructed from well documented RNAseq and targeted-NGS profiles established from serial HER2+ and TN tumors before/after NAC treatment

  2. Identify molecular signatures associated with response to NAC [ Time Frame: 5 years ]
    Comparison of serial molecular profiles

  3. Establish PDO samples exposed to NAC [ Time Frame: 5 years ]
    Percentage of PDO exposed to NAC that will parallel the patient's clinical response to NAC

  4. Evaluation of CTCs features [ Time Frame: 5 years ]
    phenotype, RNA-seq-based transcriptome


Biospecimen Retention:   Samples With DNA
Bllod and tumor tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Brest cancer females with a non metastatic cancer
Criteria

Inclusion Criteria:

  1. Woman over 18
  2. Signed consent to participate
  3. Invasive mammary adenocarcinoma proven histologically and / or cytologically
  4. Indication of CNA retention by the referring clinical team.
  5. No contraindication to CNA.
  6. Selected indication of the post-CNA surgery sequence, then radiotherapy
  7. Performance index ≤ 1 (WHO).
  8. Affiliation to a social security scheme, or beneficiary of such a scheme

Exclusion Criteria:

  1. Planned therapeutic sequence: CNA, followed by neoadjuvant radiotherapy (HIST-RIC clinical trial for example) before surgery
  2. Metastatic disease at diagnosis
  3. Patient relapsed from breast cancer precede
  4. Other malignant disease in the previous 3 years, with the exception of cervical carcinoma in situ or skin basal cell carcinoma and any other cancerous pathology considered to have been properly treated and at low risk of relapse.
  5. Woman pregnant or likely to be (without effective contraception) or breastfeeding
  6. Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent.
  7. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons

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): NCT04504747


Contacts
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Contact: Dominique GENRE, Dr 0491223778 drci.up@ipc.unicancer.fr

Locations
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France
Institut Paoli-Calmettes
Marseille, France, 13009
Contact: Dominique GENRE, Dr    0491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: François BERTUCCI, Pr         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: François BERTUCCI, Pr Institut Paoli-Calmettes
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT04504747    
Other Study ID Numbers: NEO-R-IPC 2019-041
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases