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

NCT04548960 | Unknown

• 1 other identifier: 2017-A02018-45
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

CANCER

Keywords

Resistance; Markers; Exome; Transriptome; Immunological Profil

Outcome Measures

Primary Outcomes (1)

• Combinatory analysis of genomic, transcriptomic and immunological profile

  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 Outcomes (2)

• Progression-free survival

  up to 24 months

• Over Survival

  up to 24 months

Study Arms (1)

cancer patients

OTHER

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

Interventions

cancer patients OTHER

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

cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncodesign SA: lead

Study Sites (11)

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, 69000, France

RECRUITING

Chu de Besancon

Besançon, Bourgogne-Franche-Comté, 25000, France

NOT YET RECRUITING

CGFL

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

Chu Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté, 21000, France

RECRUITING

Institut de Cancerologie de Lorraine

Nancy, Grand Est, 54000, France

NOT YET RECRUITING

Institut Godinot

Reims, Grand Est, 51100, France

RECRUITING

Hopitaux Universitaires de Strasbourg

Strasbourg, Grand Est, 67000, France

RECRUITING

Chu de Poitiers

Poitiers, Nouvelle-Aquitaine, 86000, France

RECRUITING

Institut Paoli Calmettes

Marseille, PACA, 13000, France

RECRUITING

APHP - Hôpital Beaujon

Clichy, Paris, 92110, France

RECRUITING

Institut Curie

Paris, 75000, France

RECRUITING

Related Publications (1)

• Vachenc S, Gobbo J, Moujarrebe SE, Desmoulins I, Gilabert M, Beau-Faller M, Mitry E, Girard N, Bertaut A, Dusetti N, Iovanna JL, Yousfi R, Pierrat F, Bruno R, Cueff A, Boidot R, Genne P. OncoSNIPE(R) Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients. BMC Cancer. 2022 Jan 6;22(1):41. doi: 10.1186/s12885-021-09134-3.

  PMID: 34991520 DERIVED

Related Links

• OncoSNIPE Program description

MeSH Terms

Conditions

Neoplasms

Study Officials

• FRANCOIS GHIRINGHELLI, MD

  Centre Georges François Leclerc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PHILIPPE GENNE, PhD

CONTACT

+33 3 80 78 82 60; PMONGIN@ONCODESIGN.COM

SEBASTIEN VACHENC

CONTACT

+33 3 80 78 82 60; SVACHENC@ONCODESIGN.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this study a part of samples (blood and biopsies) will be collected specifically for this study. This is why the study is therefore interventional

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: September 16, 2020
• Study Start: January 6, 2018
• Primary Completion: December 31, 2021
• Study Completion: March 31, 2023
• Last Updated: September 9, 2021

Record last verified: 2020-09

Locations

FR (11)