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

NCT02622581

Last updated date
Study Location
Pius-Hospital
Oldenburg, , 26121, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy

- Systemic therapy

Satellite Stage II/III (NSCLC):

- Confirmed non-small cell lung cancer (NSCLC)

- Informed consent no later than four weeks after start of first anti-tumor treatment

- Stage II, stage IIIA, or stage IIIB/C (UICC8) if patient is eligible for curative surgery and/or radiochemotherapy

- Systemic (chemo)therapy and/or radiation therapy and/or surgery

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


none

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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 CancerClinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
NCT02622581
  1. Oldenburg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
Official Title Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients
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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population

Main project (Metastatic NSCLC):

Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy. 5,000 patients will be patients with non-squamous cell carcinoma tested for molecular alterations at the start of first-line treatment or patients with squamous cell carcinoma. The remainder will be patients with untested non-squamous carcinoma (CRISP satellite untested patients stage IIIB/IIIC/IV).

Satellite Stage II/III (NSCLC):

800 patients with NSCLC stage II or IIIA, or with NSCLC stage IIIB/C if eligible for curative surgery and/or radiochemotherapy

Satellite SCLC:

Up to 1200 patients with SCLC (limited stage (LD) or extensive stage (ED)) if eligible for surgery and/or radio(chemo)therapy and/or systemic therapy, or are receiving best supportive care.

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.

Condition
  • 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
Intervention 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.
Study Groups/Cohorts
  • NSCLC, Non-squamous cell carcinoma

    Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy.

    3,250 patients with non-squamous cell carcinoma will be tested for molecular alterations. (CRISP)

    Intervention: Other: data collection
  • NSCLC, Squamous cell carcinoma

    Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy.

    1,750 patients with squamous cell carcinoma that possibly will be tested for molecular alterations. (CRISP)

    Intervention: Other: data collection
  • NSCLC, Non-squamous cell carcinoma (not tested)

    Patients with locally advanced or metastatic NSCLC at the start of palliative first-line systemic therapy.

    Not tested for molecular alterations (CRISP satellite untested patients stage IIIB/IIIC/IV).).

    Intervention: Other: data collection
  • NSCLC, Stage II/III
    800 patients with NSCLC stage II, or stage IIIA, or with NSCLC stage IIIB/C if they are eligible for curative surgery and/or radiochemotherapy
    Intervention: Other: data collection
  • 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
    Intervention: Other: data collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 29, 2019)
7500
Original Estimated Enrollment
 (submitted: December 3, 2015)
5000
Estimated Study Completion Date December 2025
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility 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
  • Stage IV, or stage IIIB/C (UICC8) if patient is ineligible for curative surgery and/or radiochemotherapy
  • Systemic therapy

Satellite Stage II/III (NSCLC):

  • Confirmed non-small cell lung cancer (NSCLC)
  • Informed consent no later than four weeks after start of first anti-tumor treatment
  • Stage II, stage IIIA, or stage IIIB/C (UICC8) if patient is eligible for curative surgery and/or radiochemotherapy
  • Systemic (chemo)therapy and/or radiation therapy and/or surgery

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

Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Aysun Karatas, Dr.[email protected]
Contact: Annette Hipper, Dr.[email protected]
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02622581
Other Study ID Numbers AIO-TRK-0315
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AIO-Studien-gGmbH
Study Sponsor AIO-Studien-gGmbH
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
  • Amgen
Investigators
Principal Investigator:Frank Griesinger, Prof. Dr.Pius-Hospital Oldenburg
PRS Account AIO-Studien-gGmbH
Verification Date April 2020