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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775514
Other study ID # ML28579
Secondary ID
Status Completed
Phase N/A
First received January 18, 2013
Last updated November 1, 2016
Start date October 2012
Est. completion date October 2015

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

This non-interventional study will assess the occurrence rate of non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey, and the diagnostic methods and treatments used. Data will be collected over 36 months.


Recruitment information / eligibility

Status Completed
Enrollment 32277
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participants diagnosed with non-small cell lung, colon, breast, gastric cancer and melanoma

- Participants who give consent to the collection of their information after the first record and pathological confirmation of their cancer

Exclusion Criteria:

- Participants not living in the city or representative region of the study center

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Malignant Melanoma (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region 36 months No
Primary Number of Participants with Non-Small Cell Lung Cancer (Occurrence Rate), Defined as New Cases Recorded in the Region in 1 Year Divided by (/) Population of the Region 36 months No
Primary Number of Participants with Colon Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region 36 months No
Primary Number of Participants with Breast Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region 36 months No
Primary Number of Participants with Gastric Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region 36 months No
Secondary Percentage of Participants Categorized by Tumor Size 36 months No
Secondary Percentage of Participants Categorized by Histopathology Diagnosis 36 months No
Secondary Percentage of Participants Categorized by the Staging System 36 months No
Secondary Percentage of Participants Categorized by Surgery Type 36 months No
Secondary Percentage of Participants Categorized by Type of Treatments Administered (ie, Adjuvant and Neoadjuvant Treatments) 36 months No
Secondary Percentage of Participants With Metastasis Categorized by Treatment Regimens Used (ie, First-line, Second-line, Third-line, or Forth-line Chemotherapy) 36 months No
Secondary Overall Survival (OS) 36 months No
Secondary Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 36 months No
Secondary Percentage of Participants With Family History of Cancer and Other Conditions 36 months No
Secondary Percentage of Participants With History of Another Primary Cancer 36 months No
Secondary Percentage of Participants Categorized by Diagnostic Methods 36 months No
Secondary Percentage of Participants With Metastasis 36 months No
Secondary Percentage of Participants Categorized by Tumor Localization 36 months No
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