OncoSNIPE - Study of Molecular Profiles Associated With the Development of Resistance in Solid Cancer Patients (OncoSNIPE)

September 8, 2021 updated by: Oncodesign SA

Molecular Profiles Associated With Resistance Development in Cancer Patients. Prospective Exploratory Study From 3 Cancer Locations: TNBC or Locally Advanced or Metastatic, Non-small Cell or Pancreatic or Bronchial Cancers

Precision medicine is considered to be one of the major issues in patient care. A lot of research has already proven itself with the implementation of targeted therapies including immunotherapies offering patients improved response and survival rates. But despite these major therapeutic advances, resistance to anti-cancer treatment is a major obstacle in the care of patients. Indeed, to date, many patients die of cancer, 9.6 million deaths worldwide in 2018. Nowadays, improving understanding of the mechanisms of resistance of cancer cells to anti-tumor treatments is therefore a major issue. The great diversity of molecular mechanisms involved in the phenomena of resistance to treatment, whether intrinsic (de novo, or primary) or acquired (secondary), constitutes a real therapeutic challenge. Indeed, a better understanding of the mechanisms of resistance would make it possible to explore new therapeutic strategies making it possible to circumvent these phenomena of escape in different types of cancer. It is in this context that the OncoSNIPE project was developed. The objective of this project is to identify early and / or late markers of resistance to treatment in 3 different pathologies concerned with resistance issues: triple negative breast cancer or Lum B or locally advanced or metastatic non -small-cell lung cancer or pancreatic cancer. In this project, in order to best cover the diversity of mechanisms involved in these resistances, the investigators propose a multidisciplinary approach with clinical, genomic, transcriptomic and immunological dimensions of the pathology through the data collected from 600 patients (200 for each pathology) for 4 years

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Precision medicine is considered to be one of the major issues in patient care. A lot of research has already proven itself with the implementation of targeted therapies including immunotherapies offering patients improved response and survival rates. But despite these major therapeutic advances, resistance to anti-cancer treatment is a major obstacle in the care of patients. Indeed, to date, many patients die of cancer, 9.6 million deaths worldwide in 2018. Nowadays, improving understanding of the mechanisms of resistance of cancer cells to anti-tumor treatments is therefore a major issue. The great diversity of molecular mechanisms involved in the phenomena of resistance to treatment, whether intrinsic (de novo, or primary) or acquired (secondary), constitutes a real therapeutic challenge. Indeed, a better understanding of the mechanisms of resistance would make it possible to explore new therapeutic strategies making it possible to circumvent these phenomena of escape in different types of cancer. It is in this context that the OncoSNIPE project was developed. The objective of this project is to identify early and / or late markers of resistance to treatment in 3 different pathologies concerned with resistance issues : triple negative breast cancer or lum B or locally advanced or metastatic non- small-cell lung cancer or pancreatic cancer. In this project, in order to best cover the diversity of mechanisms involved in these resistances, the investigators propose a multidisciplinary approach with clinical, genomic, transcriptomic and immunological dimensions of the pathology through the data collected from 600 patients (200 for each pathology) for 4 years.

The patient populations targeted in this study have one common thing: rapid progression of their pathology, making it possible to obtain models for evaluating markers of early and / or late responses over the period of follow-up of 2-year post-inclusion patients, and thus provide the information necessary to understand the resistance mechanisms.

To explore the phenomena of resistance, during the therapeutic response and / or the progression of the pathology, the investigators will used a multidisciplinary approach including high-throughput sequencing (Exome-seq and RNAseq) and immunological profil by ELISA . Patients will have long-term follow-up with different biological samples, at baseline (blood and biopsy) and at each tumoral evaluation or tumoral progression evaluated by medical imaging.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75000
        • Recruiting
        • Institut Curie
        • Principal Investigator:
          • Nicolas Girard, MD
        • Contact:
          • NICOLAS GIRARD, MD
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69000
        • Recruiting
        • Centre Léon Bérard
    • Bourgogne Franche Comte
      • Besancon, Bourgogne Franche Comte, France, 25000
        • Not yet recruiting
        • CHU de Besancon
        • Principal Investigator:
          • FERNANDO BAZAN, MD
        • Contact:
          • FERNANDO BAZAN, MD
      • Dijon, Bourgogne Franche Comte, France, 21000
        • Recruiting
        • CGFL
        • Contact:
          • Isabelle DESMOULINS, MD
      • Dijon, Bourgogne Franche Comte, France, 21000
        • Recruiting
        • CHU Dijon Bourgogne
        • Principal Investigator:
          • PASCAL FOUCHER, MD
        • Contact:
          • PASCAL FOUCHER, MD
    • Grand EST
      • Nancy, Grand EST, France, 54000
        • Not yet recruiting
        • Institut de Cancerologie de Lorraine
        • Principal Investigator:
          • Christelle CLEMENT-DUCHENE, MD
        • Contact:
          • Christelle CLEMENT-DUCHENE, MD
      • Reims, Grand EST, France, 51100
        • Recruiting
        • Institut Godinot
        • Principal Investigator:
          • Aude-Marie SAVOYE, MD
        • Contact:
          • Aude-Marie SAVOYE, MD
      • Strasbourg, Grand EST, France, 67000
        • Recruiting
        • Hopitaux universitaires de Strasbourg
        • Contact:
          • MICHELE BEAU-FALLER, MD
        • Principal Investigator:
          • MICHELE BEAU-FALLER, MD
    • Nouvelle-Aquitaine
      • Poitiers, Nouvelle-Aquitaine, France, 86000
        • Recruiting
        • CHU De Poitiers
        • Contact:
          • Nicolas ISAMBERT, MD
    • Paca
      • Marseille, Paca, France, 13000
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
          • Marine GILABERT, MD
        • Principal Investigator:
          • Marine GILABERT, MD
    • Paris
      • Clichy, Paris, France, 92110
        • Recruiting
        • APHP - Hôpital Beaujon
        • Contact:
          • PHILIPPE LEVY, MD
        • Principal Investigator:
          • PHILIPPE LEVY, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. General

    • Adult patient, 18 years of age or older
    • Naive chemo patient
    • Performant status: 0,1 or 2.
    • Life expectancy> 3 months
    • Subject affiliated to a social security and health insurance scheme
    • Subject having dated and signed informed consent
    • For women of childbearing age (negative pregnancy test): effective contraception

  2. Pancreatic cancer:

    • Patient receiving a biopsy, as part of the usual care of the patient:

      • Either from the primary tumor
      • Either a metastasis for a strong suspicion of locally advanced or metastatic pancreatic ductal adenocarcinoma;
    • With advanced or metastatic tumors (liver, lungs, peritoneum, others) that cannot benefit from local or locoregional treatment;
    • Presence of target lesion (s) measurable according to RECIST criteria
    • Patient who cannot be treated by surgery or radiotherapy

  3. Lung cancer:

    • Patient with histologically proven non-small cell lung cancer
    • Locally advanced stage IIIB or IV
    • Treatment with chemotherapy, targeted therapy, immunotherapy
    • Tissue available after analysis of the usual biomarkers in the event of a non-epidermoid tumor
    • Rate of tumor cells observed on biopsies must be ≥ 30%.
    • Presence of measurable target lesion or disease assessable according to RECIST criteria

  4. Breast cancer:

    • Breast cancer of recent diagnosis, histologically proven.
    • Triple negative breast cancer: negativity of estrogen and progesterone receptors in the tumor (<10%), absence of HER2 overexpression according to the IHC classification (score 0 or 1+) and / or FISH negative
    • or
    • LumB: RO positive, RP positive or negative, HER2 negative, high proliferation;
    • Stage I to III for triple negative breast cancer (including stage T4d = inflammatory cancer), Stage II or III of the UICC classification for LumB
    • Non-metastatic patient (M0 according to TNM classification)
    • Rate of tumor cells observed on biopsies must be ≥ 30%
    • Patient who cannot be treated exclusively by surgery or radiotherapy

Exclusion Criteria:

General

  • History of chemotherapy (except adjuvant completed for more than at least 6 months) or radiotherapy
  • Patient whose monitoring and treatment will not be carried out in the study health establishments;
  • Tumor not histologically proven;
  • Life expectancy of less than 3 months
  • Pregnancy or breastfeeding
  • Refusal to participate in the trial
  • Persons deprived of their liberty, persons under guardianship or curatorship
  • Inability to submit to the medical follow-up of the test for social or psychological reasons
  • No affiliation to a social security scheme or state medical aid (AME) or universal medical coverage (CMU)
  • Any condition for which participation in the protocol would present a risk or which would not make it possible to comply with the requirements of the protocol according to the investigator
  • History of other cancers in the last 5 years except cervical cancer and skin cancer of the basal or epidermoid cells treated
  • Known HIV seropositivity Specific

Pancreatic cancer:

  • Other histologies: neuroendocrine cancer, acinar cancer, pancreatic metastasis of another cancer
  • Patient who cannot benefit from chemotherapy (Performans status (PS) 3 - 4);
  • Other progressive cancer during the management of pancreatic cancer;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: cancer patients
cancer patients To explore the phenomena of resistance during the therapeutic response and/or the progression of the pathology, the investigatorswill used a multidisciplinary approach including high-throughput sequencing (Exome-seq and RNAseq) from blood and tumor samples and immunological profil by ELISA
Other: cancer patients
Blood sample RNA_seq at time of diagnostic, best response and relapse ; Biopsy Exom_seq and RNA_seq at time of diagnostic and relapse Immulogical Profiling at time of diagnostic, best response and relapse

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Combinatory analysis of genomic, transcriptomic and immunological profile
Time Frame: up to 24 months
  1. Genomic changes associated with early and/or late resistance to treatment given alone or in combination in patients [ Time Frame: Through study completion, up to 2 years ]
  2. Transcriptomic changes associated with early and/or late resistance to treatment given alone or in combination in patients [ Time Frame: Through study completion, up to 2 years ]
  3. Immunophenotypic changes associated with early and/or late resistance to treatment given alone or in combination in patients [ Time Frame: Through study completion, up to 2 years ]
up to 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: up to 24 months
Clinical data from Baseline until 24 months
up to 24 months
Over Survival
Time Frame: up to 24 months
Clinical data from Baseline until 24 months
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oncodesign SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: FRANCOIS GHIRINGHELLI, MD, Centre Georges Francois Leclerc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-A02018-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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