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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02622581
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : July 25, 2022
Sponsor:
Collaborators:
AstraZeneca
Celgene Corporation
Merck Sharp & Dohme LLC
Novartis Pharmaceuticals
Pfizer
Boehringer Ingelheim
Bristol-Myers Squibb
iOMEDICO AG
Eli Lilly and Company
Roche Pharma AG
Takeda
Amgen
Janssen-Cilag G.m.b.H
GlaxoSmithKline Research & Development Limited
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment
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 Small-cell Lung Cancer Non-small Cell Lung Cancer Stage I Other: data collection

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 12400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
Actual Study Start Date : December 2015
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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)

 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.
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)

 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.
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).).

 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.
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
 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.
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
 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.


Outcome Measures
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Primary Outcome Measures :
  1. biomarker [ Time Frame: 3 years ]
    To collect data on the frequency, methodology and results of molecular biomarker testing before first-line and later-line treatment

  2. treatment [ Time Frame: 3 years ]
    To describe systemic treatments and sequential treatments applied in real-life practice

  3. Response rate [ Time Frame: 3 years ]
    To assess effectiveness of systemic treatments in regards to response rate.

  4. progression free survival [ Time Frame: 3 years ]
    To assess effectiveness of systemic treatments in regards to progression free survival.

  5. overall survival [ Time Frame: 3 years ]
    To assess effectiveness of systemic treatments in regards overall survival.

  6. physician-reported factors [ Time Frame: 3 years ]
    To describe physician-reported factors affecting treatment decision making besides biomarker profiling

  7. supportive therapies [ Time Frame: 3 years ]
    to collect key data on specific supportive therapies

  8. changes during the project [ Time Frame: 3 years ]
    To investigate changes in diagnostics, treatment or outcome during the course of the project

  9. general health-related and individual quality of life (QoL) patient-reported outcomes [ Time Frame: 3 years ]
    To evaluate patient-reported outcomes concerning (1) general health-related and individual quality of life (QoL). and depression, (4) patient-caregiver communication

  10. physical and psychological well-being patient-reported outcomes [ Time Frame: 3 years ]
    To evaluate patient-reported outcomes concerning physical and psychological well-being.

  11. anxiety patient-reported outcomes [ Time Frame: 3 years ]
    To evaluate patient-reported outcomes concerning anxiety.


Biospecimen Retention:   Samples With DNA
All patients will be asked to give consent for their tumor samples to be used for future investigational translational research. If the patient agrees, contact details of the local pathology where the tumor sample is stored as well as the sample's identification number will be documented in the eCRF, creating the CRISP "decentralized clinically annotated tissue repository". Study sites will inform the local pathologists about the patient's consent and ask for the tissue sample to be reserved for future CRISP analyses.

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Main project (Metastatic NSCLC):

10000 patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy or receiving best supportive care (BSC). 5000 will be patients with non-squamous cell carcinoma tested for molecular alterations at the start of first-line or patients with squamous cell carcinoma (CRISP patients). The remainder will be patients with untested non-squamous carcinoma (CRISP satellite untested patients stage IIIB/IIIC/IV).

Satellite Stage I/II/III (NSCLC):

1600 patients with NSCLC stage I,II,IIIA or IIIB/C eligible for curative surgery and/or radiochemotherapy or receiving BSC.

Satellite SCLC:

Up to 1200 patients with SCLC (limited stage or extensive stage) eligible for surgery and/or radio(chemo)therapy and/or systemic therapy or receiving BSC.

Patients will be recruited in up to 150 study sites (certified lung cancer centers, comprehensive cancer centers, hospitals and office-based oncology practices) in Germany.

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622581


Contacts
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Contact: Annette Hipper, Dr. annette.hipper@aio-studien-ggmb.de
Contact: Annika Groth Annika.Groth@aio-studien-ggmbh.de

Locations
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Germany
Pius-Hospital Recruiting
Oldenburg, Germany, 26121
Contact: F. Griesinger, Prof.    +49 441 229 1611    Frank.griesinger@pius-hospital.de   
Sponsors and Collaborators
AIO-Studien-gGmbH
AstraZeneca
Celgene Corporation
Merck Sharp & Dohme LLC
Novartis Pharmaceuticals
Pfizer
Boehringer Ingelheim
Bristol-Myers Squibb
iOMEDICO AG
Eli Lilly and Company
Roche Pharma AG
Takeda
Amgen
Janssen-Cilag G.m.b.H
GlaxoSmithKline Research & Development Limited
Investigators
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Principal Investigator: Frank Griesinger, Prof. Dr. Pius-Hospital Oldenburg
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT02622581    
Other Study ID Numbers: AIO-TRK-0315
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms