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Descriptive Observational Study ALK-2016-CPHG

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie
Aix en Provence, , 13616 France
Contact
1-800-718-1021
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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating 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.

NCT03718117
Pfizer
Recruiting
Descriptive Observational Study ALK-2016-CPHG

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Descriptive Observational Study ALK-2016-CPHG
Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Descriptive Observational Study.

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

Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
18 Months
Not Provided
Non-Probability Sample
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
  • NSCLC
  • Crizotinib
  • ALK Gene Rearrangement or ROS1 Gene Rearrangement
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Same as current
December 6, 2019
December 6, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
France
 
 
NCT03718117
A8081060
ALK-2016-CPHG ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Pfizer
Pfizer
French College of General Hospital Pneumologists (CPHG)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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