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CancerNCT01775514

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

An observational study of Cancer, run by Hoffmann-La Roche at 31 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
32,277 participants
Where
31 sitesTurkey (Türkiye)
Study dates
Oct 2012to Oct 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with non-small cell lung cancer, colon cancer, breast cancer, gastric cancer and malignant melanoma in Turkey

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Turkey (Türkiye)31 sites

  • Study site

    Adana, 01220

  • Study site

    Adana, 01330

  • Study site

    Afyonkarahisar, 03200

  • Study site

    Ankara, 06100

  • Study site

    Ankara, 06200

  • Study site

    Ankara, 06280

  • Study site

    Ankara, 06500

  • Study site

    Ankara, 06800

  • Study site

    Baıkesir, 10000

  • Study site

    Bursa, 16040

  • Study site

    Bursa, 16059

  • Study site

    Denizli, 20070

  • Study site

    Diyarbakır, 21280

  • Study site

    Edirne, 22770

  • Study site

    Erzurum, 25050

  • Study site

    Gaziantep, 27100

  • Study site

    Isparta, 32260

  • Study site

    Istanbul, 34000

  • Study site

    Istanbul, 34020

  • Study site

    Istanbul, 34093

  • Study site

    Istanbul, 34300

  • Study site

    Istanbul, 34890

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35110

  • Study site

    Izmir, 35340

  • Study site

    Kayseri, 38039

  • Study site

    Konya, 42080

  • Study site

    Malatya, 44280

  • Study site

    Sıhhiye, Ankara, 06100

  • Study site

    Tokat Province, 60250

  • Study site

    Trabzon, 61080

Other trials in Turkey (Türkiye)

About this study

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

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.

Conditions
Cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01775514
Study groupRoleWhat they receive
Participants With CancerParticipants from Turkey with non-small cell lung, colon cancer, breast cancer, gastric cancer and malignant melanoma will be included.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Malignant Melanoma (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region

    Measured: 36 months

  2. 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

    Measured: 36 months

  3. Number of Participants with Colon Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region

    Measured: 36 months

  4. Number of Participants with Breast Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region

    Measured: 36 months

  5. Number of Participants with Gastric Cancer (Occurrence Rate), Defined as New Cases Recorded in the Relevant Region in 1 Year/Population of the Region

    Measured: 36 months

Secondary outcomes (13)

  1. Percentage of Participants Categorized by Tumor Size

    Measured: 36 months

  2. Percentage of Participants Categorized by Histopathology Diagnosis

    Measured: 36 months

  3. Percentage of Participants Categorized by the Staging System

    Measured: 36 months

  4. Percentage of Participants Categorized by Surgery Type

    Measured: 36 months

  5. Percentage of Participants Categorized by Type of Treatments Administered (ie, Adjuvant and Neoadjuvant Treatments)

    Measured: 36 months

  6. Percentage of Participants With Metastasis Categorized by Treatment Regimens Used (ie, First-line, Second-line, Third-line, or Forth-line Chemotherapy)

    Measured: 36 months

  7. Overall Survival (OS)

    Measured: 36 months

  8. Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: 36 months

  9. Percentage of Participants With Family History of Cancer and Other Conditions

    Measured: 36 months

  10. Percentage of Participants With History of Another Primary Cancer

    Measured: 36 months

  11. Percentage of Participants Categorized by Diagnostic Methods

    Measured: 36 months

  12. Percentage of Participants With Metastasis

    Measured: 36 months

  13. Percentage of Participants Categorized by Tumor Localization

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
32,277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01775514
Sponsor's protocol ID
ML28579
Status last verified
Nov 2016
First submitted
18 Jan 2013
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Hoffmann-La Roche at 31 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01775514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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