Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: data collection.
- Who it may be relevant to
- Registry conditions: Metastatic Non-small Cell Lung Cancer (NSCLC), Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage II, Non Small Cell Lung Cancer Stage III. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- biomarker [Time frame: 3 years]
- treatment [Time frame: 3 years]
- Response rate [Time frame: 3 years]
- progression free survival [Time frame: 3 years]
- overall survival [Time frame: 3 years]
- physician-reported factors [Time frame: 3 years]
- supportive therapies [Time frame: 3 years]
- changes during the project [Time frame: 3 years]
- general health-related and individual quality of life (QoL) patient-reported outcomes [Time frame: 3 years]
- physical and psychological well-being patient-reported outcomes [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Pius-Hospital — Oldenburg
Publications
- 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
Identifiers
NCT: NCT02622581 · AIO-TRK-0315