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

AIO-Studien

Status: Enrolling

Conditions: Non-small Cell Lung Cancer Stage II; Small-cell Lung Cancer; Metastatic Non-small Cell Lung Cancer (NSCLC); Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage I; Non Small Cell Lung Cancer Stage III

Treatments: Other: data collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02622581

AIO-TRK-0315

Details and patient eligibility

About

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

Full 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.

Enrollment: 12,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12,400 participants in 5 patient groups

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)

Treatment:

Other: data collection

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)

Treatment:

Other: data collection

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).).

Treatment:

Other: data collection

NSCLC, Stage I/II/III

Description:

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

Treatment:

Other: data collection

Small cell lung cancer (SCLC)

Description:

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

Treatment:

Other: data collection