A Non-Interventional Study of the Occurrence Rate of Non-Small Cell Lung Cancer, Colon Cancer, Breast Cancer, Gastric Cancer and Malignant Melanoma in Turkey, and Diagnosis and Treatment Characteristics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01775514
First received: January 18, 2013
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
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.

Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Occurrence Rate of Non-Small Cell Lung, Colon Cancer, Breast Cancer, Gastric Cancer and Malignant Melanoma in Turkey & Diagnosis and Treatment Characteristics Turkish "Non-Small Cell Lung-Colon-Gastric-Breast (CGB) Cancer and Malignant Melanoma" Study

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants with Malignant Melanoma (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Number of Participants with Colon Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Number of Participants with Breast Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Number of Participants with Gastric Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants Categorized by Tumor Size [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Categorized by Histopathology Diagnosis [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Categorized by the Staging System [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Categorized by Surgery Type [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Categorized by Type of Treatments Administered (ie, Adjuvant and Neoadjuvant Treatments) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Metastasis Categorized by Treatment Regimens Used (ie, First-line, Second-line, Third-line, or Forth-line Chemotherapy) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Family History of Cancer and Other Conditions [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With History of Another Primary Cancer [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Categorized by Diagnostic Methods [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Metastasis [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Categorized by Tumor Localization [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 32277
Study Start Date: October 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants With Cancer
Participants from Turkey with non-small cell lung, colon cancer, breast cancer, gastric cancer and malignant melanoma will be included.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775514

Locations
Turkey
Adana, Turkey, 01220
Adana, Turkey, 01330
Afyon, Turkey, 03200
Ankara, Turkey, 06100
Ankara, Turkey, 06200
Ankara, Turkey, 06280
Ankara, Turkey, 06500
Ankara, Turkey, 06800
Baıkesir, Turkey, 10000
Bursa, Turkey, 16040
Bursa, Turkey, 16059
Denizli, Turkey, 20070
Diyarbakir, Turkey, 21280
Edirne, Turkey, 22770
Erzurum, Turkey, 25050
Gaziantep, Turkey, 27100
Isparta, Turkey, 32260
Istanbul, Turkey, 34000
Istanbul, Turkey, 34020
Istanbul, Turkey, 34093
Istanbul, Turkey, 34300
Istanbul, Turkey, 34890
Izmir, Turkey, 35100
Izmir, Turkey, 35110
Izmir, Turkey, 35340
Kayseri, Turkey, 38039
Konya, Turkey, 42080
Malatya, Turkey, 44280
Sıhhiye, ANKARA, Turkey, 06100
Tokat, Turkey, 60250
Trabzon, Turkey, 61080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01775514     History of Changes
Other Study ID Numbers: ML28579 
Study First Received: January 18, 2013
Last Updated: August 1, 2016
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Stomach Neoplasms
Colonic Neoplasms
Breast Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 29, 2016