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Table 1 OncoSNIPE study inclusion and exclusion criteria

From: OncoSNIPE® Study Protocol, a study of molecular profiles associated with development of resistance in solid cancer patients

Inclusion criteria  
General inclusion critreria Adult patient, 18 years of age or older
Naive chemo patient
Performans 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
Specific inclusion criteria for Pancreatic ductal adenocarcinoma Patient with histologically proven PDAC or 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 PDAC
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
Rate of tumor cells observed on FFPE biopsies must be ≥ 30%, otherwise, microdissection enrichment must be carried out to reach this threshold
Specific inclusion criteria for 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 FPPE biopsies must be ≥ 30%
Presence of measurable target lesion or disease assessable according to RECIST criteria
Specific inclusion criteria for 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 FFPE biopsies must be ≥ 30%
Patient who cannot be treated exclusively by surgery or radiotherapy
Exclusion Criteria  
General Exclusion criteria 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 exclusion criteria for Pancreatic ductal adenocarcinoma Other histologies: neuroendocrine cancer, acinary cell carcinoma, pancreatic metastasis of another cancer
Patient who cannot benefit from chemotherapy (Performans status (PS) 3—4);
Other progressive cancer during the management of PDAC;
Co-morbidities: Significant and / or uncontrolled pathologies or other conditions that may affect participation in the study, such as: unstable angina, symptomatic or uncontrolled arrhythmia requiring treatment, uncontrolled hypertension, congestive heart disease class NYHA II, III or IV, myocardial infarction or stroke in the 6 months before the study; Active or uncontrolled infection or pathology (compromised) compromising the ability to assess the patient or allow the patient to complete the study; Benign illnesses not controlled or whose control could be compromised by the treatment under study, such as severe diabetes, not controlled by medical treatment
Specific exclusion criteria for Breast cancer Non-operable or metastatic breast cancer
History of breast cancer treated
Co-morbidities: Significant and / or uncontrolled pathologies or other conditions that may affect participation in the study, such as: unstable angina, symptomatic or uncontrolled arrhythmia requiring treatment, uncontrolled hypertension, congestive heart disease class NYHA II, III or IV, myocardial infarction or stroke in the 6 months before the study; Active or uncontrolled infection or pathology (compromised) compromising the ability to assess the patient or allow the patient to complete the study; Benign illnesses not controlled or whose control could be compromised by the treatment under study, such as severe diabetes, not controlled by medical treatment
Specific exclusion criteria for Lung cancer Small cell lung cancer
Stage I to IIIa non-small cell lung cancer
Treatment by curative radiotherapy or radio-chemotherapy