Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
NCT ID: NCT02622581
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
12400 participants
OBSERVATIONAL
2015-12-31
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NSCLC, Non-squamous cell carcinoma
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.
At least 3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP)
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.
NSCLC, Squamous cell carcinoma
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.
At least 1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP)
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.
NSCLC, Non-squamous cell carcinoma (not tested)
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care.
Up to 5,000 patients not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).).
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.
NSCLC, Stage I/II/III
Up to 1600 patients with NSCLC stage I, or stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy, or are receiving best supportive care
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.
Small cell lung cancer (SCLC)
Up to 1200 patients with SCLC (limited stage (LD) or extensive stage (ED)) if they are eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, or are receiving best supportive care
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Celgene Corporation
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Pfizer
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
iOMEDICO AG
INDUSTRY
Eli Lilly and Company
INDUSTRY
Roche Pharma AG
INDUSTRY
Takeda
INDUSTRY
Amgen
INDUSTRY
Janssen-Cilag G.m.b.H
INDUSTRY
GlaxoSmithKline
INDUSTRY
Daiichi Sankyo
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Gilead Sciences
INDUSTRY
AIO-Studien-gGmbH
OTHER
Responsible Party
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Principal Investigators
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Frank Griesinger, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Pius-Hospital Oldenburg
Locations
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Pius-Hospital
Oldenburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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):2201336. doi: 10.1183/13993003.01336-2022. Print 2023 Feb.
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 in routine care: Analysis of the first 3,717 patients in the German prospective, observational, nation-wide CRISP Registry (AIO-TRK-0315). Lung Cancer. 2021 Feb;152:174-184. doi: 10.1016/j.lungcan.2020.10.012. Epub 2020 Nov 2.
Related Links
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AIO - Working Group for Medical Oncology from the German Cancer Society
Other Identifiers
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AIO-TRK-0315
Identifier Type: -
Identifier Source: org_study_id
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