Renal Cell CarcinomaTURCOSNCT01585974
Duration of Treatment With Tyrosine Kinase Inhibitors in the Treatment of Metastatic Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, run by Bayer at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to Nov 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: Patients diagnosed as metastatic renal cell carcinoma and could not tolerate previous cytokine therapy within the first month of treatment
Who may be able to join
- To be diagnosed as metastatic renal cell carcinoma
- Previous cytokine therapy
- To sign informed consent form (ICF)
Who cannot join
- Patients not willing to sign informed consent form or who withdraw their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Treatment With TKIs in the Treatment of Metastatic Renal Cell Carcinoma
This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.
- Conditions
- Renal Cell Carcinoma
- Being tested
- No intervention
- Keywords
- Renal Cell Carcinoma, TKI, Turkey, Observational
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
All dosage, frequency and duration for drugs will be under the decision of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product
Measured: After 2 years
Secondary outcomes (2)
Incidence of treatment-emergent adverse events (TEAE)
Measured: After 2 years
Change of Tumor status
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585974
- Sponsor's protocol ID
- 16263
- Other IDs
- NX1211TR
- Acronym
- TURCOS
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2012
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Benekli M, Gumus M, Ozkan M, Dane F, Elkiran ET, Cicin I, Sevinc A, Aliustaoglu M, Isikdogan A, Meydan N, Oksuzoglu B, Ozyilkan O, Artac M, Ozdemir F, Kilickap S. Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study. J Oncol Pharm Pract. 2021 Oct;27(7):1623-1630. doi: 10.1177/1078155220963535. Epub 2020 Oct 13.
PubMed 33050804
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Treatment With TKIs in the Treatment of Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01585974
- Acronym / sponsor ID
- TURCOS / 16263
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, TKI, Turkey, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, non-interventional, non-controlled, multi-center, observational cohort study. The medication is prescribed within the regular practice of the physician. Duration and dosage of treatment is solely at the discretion of the attending physician. The primary objective of this study is to assess duration of treatment in Turkish renal cell carcinoma patients treated with TKIs (Tyrosine Kinase Inhibitors) who could not tolerate prior cytokine treatment within the first month of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as metastatic renal cell carcinoma and could not tolerate previous cytokine therapy within the first month of treatment
Key inclusion criteria (3 listed)
- To be diagnosed as metastatic renal cell carcinoma
- Previous cytokine therapy
- To sign informed consent form (ICF)
Key exclusion criteria (1 listed)
- Patients not willing to sign informed consent form or who withdraw their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAll dosage, frequency and duration for drugs will be under the decision of the treating physician | Other | Group 1 |
Primary outcome
Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product
Time frame: After 2 years
2 secondary outcomes
Incidence of treatment-emergent adverse events (TEAE)
Time frame: After 2 years
Change of Tumor status
Time frame: Baseline and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Derived from this study: PubMed 33050804Benekli M, Gumus M, Ozkan M, Dane F, Elkiran ET, Cicin I, Sevinc A, Aliustaoglu M, Isikdogan A, Meydan N, Oksuzoglu B, Ozyilkan O, Artac M, Ozdemir F, Kilickap S. Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study. J Oncol Pharm Pract. 2021 Oct;27(7):1623-1630. doi: 10.1177/1078155220963535. Epub 2020 Oct 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Bayer at 1 site 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 3 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 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Duration of treatment: from start of tyrosine kinase inhibitor treatment to permanent discontinuation of the product (time frame: After 2 years). 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 NCT01585974, which also lists 1 linked publication.
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 19 Oct 2016.