Clinical trial · Observational
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
NCT02622581CI-TRIAL-00086140CRISPrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non Small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- NSCLC, Non-squamous cell carcinoma
- description
- 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)
- interventionNames
- Other: data collection
- label
- NSCLC, Squamous cell carcinoma
- description
- 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)
- interventionNames
- Other: data collection
- label
- NSCLC, Non-squamous cell carcinoma (not tested)
- description
- 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).).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDSebastian 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 Registry (AIO-TRK-0315). Int J Cancer. 2024 Jun 1;154(11):1967-1978. doi: 10.1002/ijc.34868. Epub 2024 Feb 8. PMID 38329180
- DERIVEDMetzenmacher 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. PMID 36180086
- DERIVEDGriesinger 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. PMID 33358484