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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:
ClinicalTrials.gov Identifier:
NCT01775514
First Posted: January 25, 2013
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Percentage of Participants Categorized by Tumor Size [ Time Frame: 36 months ]
  • Percentage of Participants Categorized by Histopathology Diagnosis [ Time Frame: 36 months ]
  • Percentage of Participants Categorized by the Staging System [ Time Frame: 36 months ]
  • Percentage of Participants Categorized by Surgery Type [ Time Frame: 36 months ]
  • Percentage of Participants Categorized by Type of Treatments Administered (ie, Adjuvant and Neoadjuvant Treatments) [ Time Frame: 36 months ]
  • 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 ]
  • Overall Survival (OS) [ Time Frame: 36 months ]
  • Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 36 months ]
  • Percentage of Participants With Family History of Cancer and Other Conditions [ Time Frame: 36 months ]
  • Percentage of Participants With History of Another Primary Cancer [ Time Frame: 36 months ]
  • Percentage of Participants Categorized by Diagnostic Methods [ Time Frame: 36 months ]
  • Percentage of Participants With Metastasis [ Time Frame: 36 months ]
  • Percentage of Participants Categorized by Tumor Localization [ Time Frame: 36 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 18, 2013
First Posted: January 25, 2013
Last Update Posted: November 2, 2016
Last Verified: November 2016

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