Metastatic Kidney CancerCOG-ANGIONCT01336231
Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer
An observational study of Metastatic Kidney Cancer, run by Centre Francois Baclesse at 6 sites in France.
Trial summary
Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Kidney Cancer
- How many people
- 82 participants
- Where
- 6 sitesFrance
- Study dates
- Oct 2008to Jun 2013
- 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 with a metastatic kidney cancer and must beginning a treatment by antiangiogenic
Who may be able to join
- Patient (e) Age (e) over 18 years
- Kidney cancer metastatic or locally advanced
- Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together
- Proposed treatment in first line or second line
- Brain imaging not finding brain metastases
- Having signed the informed consent of study participation
- The patient may have received prior anti-angiogenic
Who cannot join
- Cancer of the kidney other than primitive
- Previous history of cancer other than kidney cancer in complete remission for less than 5 years
- Patients under 18 years
- Patients whose treatment is associated with chemotherapy
- disorders of cognitive functions to existing treatment delivery
- Pathology psychiatric evolutionary
Show all 14Show fewer
- Refusal of participation
- Patient unable to respond to cognitive tests
- Drug use
- Heavy drinking (WHO criteria)
- History of stroke
- History of head trauma
- Brain metastases known
- MMS below normal compared to existing standards for age and socio-cultural
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre François BACLESSE
Caen, Calvados, 14076
Hôpital Georges Pompidou
Paris, Île-de-France Region, 75908
Centre Henri Becquerel
Rouen, Seine Maritime, 76000
CHU
Rouen, Seine Maritime, 76038
CHU
Strasbourg, 67091
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study
Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer
- Conditions
- Metastatic Kidney Cancer
- Keywords
- quality of life, cognitive functions, antiangiogenic agents, kidney cancer, metastatic
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients group | Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of fatigue, memory problems and attentional
Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer.
Measured: up to 12 months after treatment
Secondary outcomes (7)
Parameters of quality of life
Studying the different parameters of quality of life and their evolution over time.
Measured: up to 12 months after treatment
disorders of cognitive functions
Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue.
Measured: up to 12 months after treatment
biological disturbances
Search for biological disturbances may be related to fatigue and cognitive disorders.
Measured: up to 9 months after treatment
Impact of anxiety and depression
Assessing the impact of anxiety and depression at the waning of treatment
Measured: up to 12 months after treatment
List of symptoms
Compare the list of symptoms considered important by the patient compared to those recorded in the medical record.
Measured: up to 12 months after treatment
Impact on the sexuality
sess the impact on the sexuality of patients with the waning of treatment
Measured: up to 12 months after treatment
Effects of different antiangiogenic agents
Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used
Measured: up to 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startOct 2008
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Kidney CancerStudies of the same condition, open and under way.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Florence JOLY-LOBBEDEZ, PD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336231
- Sponsor's protocol ID
- COG-ANGIO
- Acronym
- COG-ANGIO
- Status last verified
- Jul 2016
- First submitted
- 12 Apr 2011
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer : a Pilot Study
- ClinicalTrials.gov ID
- NCT01336231
- Acronym / sponsor ID
- COG-ANGIO / COG-ANGIO
- Conditions
- Metastatic Kidney Cancer
- Keywords
- quality of life, cognitive functions, antiangiogenic agents, kidney cancer, metastatic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Apr 2011 (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.
Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients group | – | –Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic
Key inclusion criteria (7 listed)
- Patient (e) Age (e) over 18 years
- Kidney cancer metastatic or locally advanced
- Anti-angiogenic or targeted therapy (bevacizumab, sorafenib, sunitinib, temsirolimus, another molecule or developing or having obtained authorization in this indication) may be associated with interferon or combined together
- Proposed treatment in first line or second line
- Brain imaging not finding brain metastases
Key exclusion criteria (14 listed)
- Cancer of the kidney other than primitive
- Previous history of cancer other than kidney cancer in complete remission for less than 5 years
- Patients under 18 years
- Patients whose treatment is associated with chemotherapy
- disorders of cognitive functions to existing treatment delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of fatigue, memory problems and attentional
Time frame: up to 12 months after treatment
Assessing the impact of fatigue, memory problems and attentional induced by an anti-angiogenic and study their evolution over time in patients with metastatic kidney cancer.
7 secondary outcomes
Parameters of quality of life
Time frame: up to 12 months after treatment
disorders of cognitive functions
Time frame: up to 12 months after treatment
biological disturbances
Time frame: up to 9 months after treatment
Impact of anxiety and depression
Time frame: up to 12 months after treatment
List of symptoms
Time frame: up to 12 months after treatment
Impact on the sexuality
Time frame: up to 12 months after treatment
Effects of different antiangiogenic agents
Time frame: up to 12 months after treatment
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2016.
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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.
Florence JOLY-LOBBEDEZ, PD principal investigator
Centre François Baclesse
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Kidney Cancer, run by Centre Francois Baclesse at 6 sites in France.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.
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?
Impact of fatigue, memory problems and attentional (time frame: up to 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2016.