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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