Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients

Обзор

Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany

Подробное описание

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-life practice, is crucial to evaluate and improve the quality of care for patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).

The purpose of CRISP is to set up a national clinical research platform to document uniform data on the molecular testing, treatment, course of disease in patients with NSCLC or SCLC. A particular focus is on molecular biomarker testing before the start of first-line treatment of patients with advanced or metastatic NSCLC. The data shall be used to assess the current state of care and to develop recommendations concerning topics that could be improved.

PRO assessment will provide large-scale data on quality of life and anxiety/depression for real-life patients with NSCLC or SCLC in routine practice. In addition, two questionnaires (concerning individual quality of life and patient-caregiver communication) will be validated in German patients with metastatic NSCLC.

Furthermore, CRISP will set up a decentralized clinically annotated tissue repository for future collaborative, investigational scientific biomarker testing.

Вмешательства

• Другое data collection
  Baseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.

Первичные конечные точки

• biomarker [Срок оценки: 3 years]
• treatment [Срок оценки: 3 years]
• Response rate [Срок оценки: 3 years]
• progression free survival [Срок оценки: 3 years]
• overall survival [Срок оценки: 3 years]
• physician-reported factors [Срок оценки: 3 years]
• supportive therapies [Срок оценки: 3 years]
• changes during the project [Срок оценки: 3 years]
• general health-related and individual quality of life (QoL) patient-reported outcomes [Срок оценки: 3 years]
• physical and psychological well-being patient-reported outcomes [Срок оценки: 3 years]

Критерии участия

Критерии включения

Patients who meet all of the following criteria are eligible for the project:

• Age ≥ 18 years
• Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments

Main project (Metatstatic NSCLC):

• Confirmed non-small cell lung cancer (NSCLC)
• Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only"
• Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
• Systemic therapy or best supportive care

Satellite Stage I/II/III (NSCLC):

• Confirmed non-small cell lung cancer (NSCLC)
• Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
• Stage I, Stage II, stage IIIA, or stage IIIB/C (UICC8)
• Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Satellite SCLC

• Confirmed Small cell lung cancer (SCLC)
• Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving "best supportive care only" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)
• Systemic (chemo)therapy and/or radiation therapy and/or surgery or best supportive care

Критерии исключения

none

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 1 центр

• Pius-Hospital — Oldenburg

Публикации

• Sebastian M, Eberhardt WEE, von der Heyde E, Dorfel S, Wiegand J, Schiefer C, Losem C, Janicke M, Fleitz A, Zacharias S, Kaiser-Osterhues A, Hipper A, Dietel C, Bleckmann A, Benkelmann R, Boesche M, Grah C, Muller A, Griesinger F, Thomas M; CRISP Registry Group. Patient-reported outcomes in advanced NSCLC before and during the COVID-19 pandemic: Real-world data from the German prospective CRISP Re PMID 38329180
• Metzenmacher M, Griesinger F, Hummel HD, Elender C, Schafer H, de Wit M, Kaiser U, Kern J, Janicke M, Spring L, Zacharias S, Kaiser-Osterhues A, Groth A, Hipper A, Zaun G, Dorfel S, Guldenzoph B, Muller L, Uhlig J, Thomas M, Sebastian M, Eberhardt WEE; CRISP Registry Group. Prognostic factors in nonsmall cell lung cancer: insights from the German CRISP registry. Eur Respir J. 2023 Feb 2;61(2):2201 PMID 36180086
• Griesinger F, Eberhardt W, Nusch A, Reiser M, Zahn MO, Maintz C, Bernhardt C, Losem C, Stenzinger A, Heukamp LC, Buttner R, Marschner N, Janicke M, Fleitz A, Spring L, Sahlmann J, Karatas A, Hipper A, Weichert W, Heilmann M, Sadjadian P, Gleiber W, Grah C, Waller CF, Reck M, Rittmeyer A, Christopoulos P, Sebastian M, Thomas M; CRISP Registry Group. Biomarker testing in non-small cell lung cancer i PMID 33358484

Идентификаторы

NCT: NCT02622581 · AIO-TRK-0315

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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