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

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ClinicalTrials.gov Identifier: NCT02622581
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
AstraZeneca
Celgene Corporation
Merck Sharp & Dohme Corp.
Novartis Pharmaceuticals
Pfizer
Boehringer Ingelheim
Bristol-Myers Squibb
iOMEDICO AG
Eli Lilly and Company
Roche Pharma AG
Takeda
Information provided by (Responsible Party):
AIO-Studien-gGmbH

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 advanced or metastatic NSCLC in Germany

Condition or disease Intervention/treatment
Metastatic Non-small Cell Lung Cancer (NSCLC) 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 metastatic non-small cell lung cancer (NSCLC). 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 advanced or metastatic NSCLC not amenable to curative treatment. A particular focus is on molecular biomarker testing of patients before the start of first-line treatment. 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 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 Type : Observational [Patient Registry]
Estimated Enrollment : 5000 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
Study Start Date : December 2015
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Non-squamous cell carcinoma
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.

Squamous cell carcinoma
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.

Non-squamous cell carcinoma (not tested)
Not tested for molecular alterations (CRISP-Satellite).
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.




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.


Information from the National Library of Medicine

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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
Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy. Of all patients recruited, 3,250 patients with nonsquamous cell carcinoma will be tested for molecular alterations at the start of first-line treatment (CRISP patients). 1,750 patients with squamous can be tested for molecular alterations at the start of first-line treatment (CRISP patients). The remainder will be patients with untested non-squamous carcinoma (CRISP satellite patients). 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:

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Stage IV or stage IIIB (UICC7) if patient is ineligible for curative surgery and/or radiochemotherapy
  • Informed consent no later than four weeks after start of (palliative) firstline treatment
  • Age ≥ 18 years
  • Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments

Exclusion Criteria:


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
Contact: Aysun Karatas, Dr. aysun.karatas@aio-studien-ggmbh.de
Contact: Annette Hipper, Dr. annette.hipper@aio-studien-ggmbh.de

Locations
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 Corp.
Novartis Pharmaceuticals
Pfizer
Boehringer Ingelheim
Bristol-Myers Squibb
iOMEDICO AG
Eli Lilly and Company
Roche Pharma AG
Takeda
Investigators
Principal Investigator: Frank Griesinger, Prof. Dr. Pius-Hospital Oldenburg

Additional Information:
Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT02622581     History of Changes
Other Study ID Numbers: AIO-TRK-0315
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases