İleri Evre Solid Tümörlerde Geniş Moleküler Profilleme Paneli ile Sınırlı Moleküler Profilleme Panelinin Katkısının Değerlendirilmesi

Sade dilde özet

Bu çalışma, ileri evre solid tümörü (advanced solid tumors) olan hastalarda, geniş kapsamlı bir moleküler test panelinin dar kapsamlı bir panele kıyasla ek fayda sağlayıp sağlamadığını kan ve tümör örnekleri üzerinden değerlendirmiştir. Çalışmaya 18 yaş ve üzeri, kemoterapi görmekte olan ve doku örneği verebilen hastalar alınmıştır. Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

Centre Leon Berard

Müdahale

Blood and tumor samples

Başlangıç

29.06.2017

Tahmini bitiş

23.11.2021

Ülkeler

France

İlgili genler

Merkezler

• Bordeaux, France
• Clermont-Ferrand, France
• Dijon, France
• Lille, France
• Lyon, France
• Lyon, France
• Marseille, France
• Marseille, France
• Montpellier, France
• Paris, France
• Paris, France
• Rennes, France
• Saint-Herblain, France
• Saint-Priest-en-Jarez, France
• Toulouse, France

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Male or female patient aged ≥ 18 years at time of inform consent signature.
* Currently treated by a first or a second line of chemotherapy for their advanced cancer (local relapse or metastatic; Immunotherapies, Endocrine therapies and Targeted therapies are not considered as a line of chemotherapy).
* Histologically confirmed diagnosis of advanced (local relapse or metastatic), incurable solid tumors from any histological types (except those listed in exclusion criteria 3).
* I4. Availability of an adequate tumor sample to be sent imperatively to the CLB within 15 days after ICF signature by order of preference either (i1) a tumor archival FFPE block not older than 3 months prior to ICF signature or if not available :(ii2) a dedicated biopsy from one accessible lesion visible by medical imaging and accessible to percutaneous sampling with a diameter of at least 10 mm or if not feasible (3) an archival tumor sample (primary tumor or metastatic lesion) not older than 3 years at time of ICF signature. Quality (at least 20-30% of tumor cells) and quantity (sample size surface area \> 5mm2 and \> 90um depth) of the tumor sample have to be confirmed mandatorily within 7 days by a central pathological review before confirmation of inclusion.
* Patient's disease which is not susceptible to progress during the next 45 days following the ICF signature.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
* Adequate organ and marrow function based on a medical records (within 21 days before randomization) as defined below :

  * Hemoglobin ≥ 9.0 g/dL
  * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  * Platelets ≥ 100 x 109/L
  * Lymphocyte count ≥ 1 x 109/L
  * Serum creatinine CL \> 50 mL/min per 1.73m2 using MDRD or CKD-EPI
  * AST and ALT ≤ 2.5 Upper Limit Normal (ULN) (up to 5 ULN may be tolerated in case of liver metastases)
  * Serum bilirubin ≤ 1. 5 ULN (in the absence of Gilbert's syndrome).
* Patient should understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
* Patient must be covered by a medical insurance.

Exclusion Criteria:

* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
* Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate an anti-cancer treatment and its procedures (these conditions include but are not limited to severely impaired lung function, active gastrointestinal tract ulceration, acute or chronic uncontrolled liver disease/or severe renal disease, uncontrolled diabetes, history of HIV infection/or active viral infection (HBV, HCV), history of organ allograft or patient taking immunosuppressive treatment).
* Patient with the following advanced cancers :

  * Cancer bearing one of the oncogenic driver mutation: Colorectal cancer : KRAS, NRAS, HRAS and BRAF/Lung cancer: ALK, EGFR, ROS or MET/Breast cancers : RH+ and/or HER2+
  * High-grade serous ovarian cancers platinum-sensitive,
  * Liposarcoma.
  * Melanoma: BRAF
* Patient with non assessable tumor sample.
* Patient already included in this study for a type of cancer, can't be included a second time for the same cancer or for any other type of cancer.
* Pregnant or breastfeeding woman