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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01775514
First received: January 18, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This non-interventional study will assess the occurrence rate of colon, breast a nd gastric cancer and of malignant melanoma in Turkey and the diagnostic methods and treatments used. Data will be collected over 12 months.


Condition
Breast Cancer, Colorectal Cancer, Gastric Cancer, Malignant Melanoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: OCCURRENCE RATE OF COLON CANCER, BREAST CANCER, GASTRIC CANCER AND MALIGNANT MELANOMA IN TURKEY & DIAGNOSIS AND TREATMENT CHARACTERISTICS

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Occurrence rate of colon cancer, defined as new cases recorded in the relevant region in 1 year / population of the region [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence rate of breast cancer, defined as new cases recorded in the relevant region in 1 year / population of the region [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence rate of gastric cancer, defined as new cases recorded in the relevant region in 1 year / population of the region [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Occurrence rate of malignant melanoma, defined as new cases recorded in the relevant region in 1 year / population of the region [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment regimens used [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pathological analysis of tumors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence/type of surgical interventions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Treatment regimens used in patients who have progressed to metastatic stage [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 25000
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with colon, breast or gastric cancer or malignant melanoma

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age, diagnosed with colon, breast or gastric cancer of malignant melanoma
  • Consent to collection of patient and family history, demographic and disease related information

Exclusion Criteria:

  • N/A
  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

Contacts
Contact: Reference Study ID Number: ML28579 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Turkey
Recruiting
Adana, Turkey, 01220
Recruiting
Adana, Turkey, 01330
Recruiting
Afyon, Turkey, 03200
Recruiting
Ankara, Turkey, 06280
Recruiting
Ankara, Turkey, 06200
Recruiting
Ankara, Turkey, 06800
Recruiting
Ankara, Turkey, 06500
Recruiting
Ankara, Turkey, 06100
Recruiting
Ba?kesir, Turkey, 10000
Recruiting
Bursa, Turkey, 16040
Active, not recruiting
Bursa, Turkey, 16059
Recruiting
Denizli, Turkey, 20070
Recruiting
Diyarbakir, Turkey, 21280
Recruiting
Edirne, Turkey, 22770
Recruiting
Erzurum, Turkey, 25050
Recruiting
Gaziantep, Turkey, 27100
Recruiting
Isparta, Turkey, 32260
Recruiting
Istanbul, Turkey, 34300
Recruiting
Istanbul, Turkey, 34000
Recruiting
Istanbul, Turkey, 35100
Recruiting
Istanbul, Turkey, 34020
Recruiting
Istanbul, Turkey, 34890
Recruiting
Izmir, Turkey, 35110
Not yet recruiting
Izmir, Turkey, 35100
Recruiting
Izmir, Turkey, 35340
Recruiting
Kayseri, Turkey, 38039
Recruiting
Konya, Turkey, 42080
Recruiting
Malatya, Turkey, 44280
Recruiting
S?hhiye, ANKARA, Turkey, 06100
Recruiting
Tokat, Turkey, 60250
Recruiting
Trabzon, Turkey, 61080
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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 19, 2014
Health Authority: Turkey: Ministry of Health

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

ClinicalTrials.gov processed this record on August 28, 2014