Descriptive Observational Study ALK-2016-CPHG

NCT03718117

Last updated date
Study Location
Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie
Aix en Provence, , 13616, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
NSCLC, Crizotinib, ALK Gene Rearrangement or ROS1 Gene Rearrangement
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

- Age ≥ 18 years

- Locally advanced or metastatic NSCLC

- Patient ALK gene rearrangement or ROS1 gene rearrangement

- Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment

- Patient followed up by a physician in a hospital pulmonary medicine department

- Subject of reproductive age, using an effective method of contraception

- Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.

Non-inclusion criteria

- Patient included within the scope of an interventional therapeutic trial

- Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement

- Patient not available for follow-up throughout the duration of the study

- Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.

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NSCLC, Crizotinib, ALK Gene Rearrangement or ROS1 Gene RearrangementDescriptive Observational Study ALK-2016-CPHG
NCT03718117
  1. Aix en Provence,
  2. Amiens,
  3. Avignon,
  4. Beauvais,
  5. Beziers,
  6. Cannes,
  7. Chalon sur Saone,
  8. Colmar Cedex,
  9. Contamine sur Arve,
  10. La Roche Sur Yon Cedex 9,
  11. La Roche Sur Yon,
  12. Le Mans,
  13. Libourne,
  14. Longjumeau,
  15. Macon cedex,
  16. Marseille,
  17. Mulhouse,
  18. Orleans,
  19. Pringy,
  20. Troyes,
  21. Villefranche sur Saone,
  22. Chambery,
  23. Aulnay sous Bois,
  24. Thonon les Bains,
  25. Frejus,
  26. Saint Pierre La Réunion,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Descriptive Observational Study ALK-2016-CPHG
Official Title CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.
Brief Summary

Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Detailed Description Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 18 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with ALK positive or ROS1-positive Locally advanced or metastatic non-small cell lung cancer NSCLC, initiated in the previous 3 months or participants initiating crizotinib treatment regardless of the line of treatment
Condition
  • NSCLC
  • Crizotinib
  • ALK Gene Rearrangement or ROS1 Gene Rearrangement
Intervention Not Provided
Study Groups/Cohorts Not Provided
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 Completed
Actual Enrollment
 (submitted: September 16, 2020)
71
Original Estimated Enrollment
 (submitted: October 22, 2018)
70
Actual Study Completion Date July 1, 2020
Actual Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  • Age ? 18 years
  • Locally advanced or metastatic NSCLC
  • Patient ALK gene rearrangement or ROS1 gene rearrangement
  • Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
  • Patient followed up by a physician in a hospital pulmonary medicine department
  • Subject of reproductive age, using an effective method of contraception
  • Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.

Non-inclusion criteria

  • Patient included within the scope of an interventional therapeutic trial
  • Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
  • Patient not available for follow-up throughout the duration of the study
  • Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03718117
Other Study ID Numbers A8081060
ALK-2016-CPHG ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators French College of General Hospital Pneumologists (CPHG)
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020