Prognostic factors in nonsmall cell lung cancer: insights from the German CRISP registry.
Martin Metzenmacher, Frank Griesinger, Horst-Dieter Hummel...
https://pubmed.ncbi.nlm.nih.gov/36180086Actively Recruiting
Age: 18Years +
All Genders
ID02622581
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
Led by AIO-Studien-gGmbH · Updated on 2025-02-18
12400
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
A
AIO-Studien-gGmbH
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the real-life treatment, molecular biomarker testing, and outcomes of patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) in Germany. The study aims to understand the current quality of care by collecting detailed data on patients with advanced or metastatic NSCLC and SCLC, focusing especially on molecular testing before first-line treatment. It also seeks to assess quality of life and mental health aspects, including anxiety and depression, for patients in routine practice. This is an observational research platform involving multiple groups of patients with different stages of NSCLC and SCLC. Patients are enrolled as they start palliative systemic therapy, receive best supportive care, or undergo curative treatments like surgery or radiochemotherapy. The study collects comprehensive data on biomarker testing, treatment decisions, therapies, and outcomes, updated every three months. It also validates questionnaires about quality of life and patient-caregiver communication and establishes a tissue repository for future biomarker research. Participants provide informed consent and complete patient-reported outcome assessments. Data collected include demographics, tumor details, treatments, response, progression, survival, and supportive care. Assessments cover physical, psychological well-being, and anxiety over three years. The study does not involve experimental treatments but monitors patients' health and treatment courses in real-world settings. Participants remain under their usual medical care during the study, which continues until 2027.
CONDITIONS
Brief Title
Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to understand and willing to sign written informed consent
- Willing to complete patient-reported outcome assessments
- Confirmed non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
- For metastatic NSCLC: stage IV or stage IIIB/C if ineligible for curative surgery or radiochemotherapy
- Informed consent given within four weeks after starting first-line systemic treatment or diagnosis if receiving best supportive care
- For early stage NSCLC (stage I, II, IIIA, or IIIB/C): consent within four weeks after starting first anti-tumor treatment or diagnosis if receiving best supportive care
- For SCLC: consent within four weeks after starting first anti-tumor treatment or diagnosis if receiving best supportive care
- Receiving systemic therapy, radiotherapy, surgery, or best supportive care
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 4 weeks after starting first-line treatment or diagnosis
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 3 years
Participants are observed to document molecular testing, treatments, and outcomes including quality of life and psychological well-being in routine practice.
Visits at least every 3 months to update data
Trial Site Locations
Total: 1 location
1
Pius-Hospital
Oldenburg, Germany, 26121
Actively Recruiting
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Research Team
A
Annika Groth
P
Paula Ludwig
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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Published Research Related To This Trial
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).
Frank Griesinger, Wilfried Eberhardt, Arnd Nusch...
https://pubmed.ncbi.nlm.nih.gov/33358484