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CANCEROncoSNIPENCT04548960

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

A study testing cancer patients in people with CANCER, run by Oncodesign SA at 11 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CANCER
What is being tested?
cancer patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
11 sitesFrance
Study dates
6 Jan 2018to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 31Show fewer
  • 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
  • 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
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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;

Trial locations and contacts

11 sites in 1 country.

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

11 sites in 1 country

France11 sites, 11 recruiting

  • Chu de Besancon

    Besançon, Bourgogne-Franche-Comté, 25000

    FERNANDO BAZAN, MD

    FERNANDO BAZAN, MD

    Not yet recruiting

  • APHP - Hôpital Beaujon

    Clichy, Paris, 92110

    PHILIPPE LEVY, MD

    PHILIPPE LEVY, MD

    Recruiting

  • CGFL

    Dijon, Bourgogne-Franche-Comté, 21000

    ISABELLE DESMOULINS, MD

    ISABELLE DESMOULINS, MD

    Recruiting

  • Chu Dijon Bourgogne

    Dijon, Bourgogne-Franche-Comté, 21000

    PASCAL FOUCHER, MD

    PASCAL FOUCHER, MD

    Recruiting

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69000

    CHRISTELLE DE LA FOUCHARDIERE, MD

    CHRISTELLE DE LA FOUCHARDIERE, MD

    Recruiting

  • Institut Paoli Calmettes

    Marseille, PACA, 13000

    MARINE GILABERT, MD

    MARINE GILABERT, MD

    Recruiting

  • Institut de Cancerologie de Lorraine

    Nancy, Grand Est, 54000

    Christelle CLEMENT-DUCHÊNE, MD

    CHRISTELLE CLEMENT-DUCHÊNE, MD

    Not yet recruiting

  • Institut Curie

    Paris, 75000

    NICOLAS GIRARD, MD

    NICOLAS GIRARD, MD

    Recruiting

  • Chu de Poitiers

    Poitiers, New Aquitaine, 86000

    NICOLAS ISAMBERT, MD

    NICOLAS ISAMBERT, MD

    Recruiting

  • Institut Godinot

    Reims, Grand Est, 51100

    AUDE-MARIE SAVOYE, MD

    AUDE-MARIE SAVOYE, MD

    Recruiting

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, Grand Est, 67000

    MICHELE BEAU-FALLER, MD

    MICHELE BEAU-FALLER, MD

    Recruiting

Other trials in France

About this study

Official title: 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

Read the 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.

Conditions
CANCER
Being tested
cancer patients
Keywords
Resistance, Markers, Exome, Transriptome, Immunological Profil
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cancer patientsOther

    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

Study groups in NCT04548960
Study groupRoleWhat they receive
cancer patientsOthercancer 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
Receives: Other: cancer patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 ]

    Measured: up to 24 months

Secondary outcomes (2)

  1. Progression-free survival

    Clinical data from Baseline until 24 months

    Measured: up to 24 months

  2. Over Survival

    Clinical data from Baseline until 24 months

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start6 Jan 2018
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04548960
Sponsor's protocol ID
2017-A02018-45
Acronym
OncoSNIPE
Status last verified
Sep 2020
First submitted
6 Jul 2020
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34991520

Questions about this trial

What is this clinical trial studying?

A study testing cancer patients in people with CANCER, run by Oncodesign SA at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact PHILIPPE GENNE, PhD (+33 3 80 78 82 60, PMONGIN@ONCODESIGN.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combinatory analysis of genomic, transcriptomic and immunological profile (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04548960, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.

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