Impact on Quality of Life, Fatigue and Cognitive Function in Anti-angiogenesis in Patients With Metastatic Kidney Cancer (COG-ANGIO)

July 20, 2016 updated by: Centre Francois Baclesse

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • CHU
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre Francois Baclesse
    • Ile de France
      • Paris, Ile de France, France, 75908
        • Hopital Georges Pompidou
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76000
        • Centre Henri Becquerel
      • Rouen, Seine Maritime, France, 76038
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients group
Patients with a metastatic kidney cancer and must beginning a treatment by antiangiogenic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parameters of quality of life
Time Frame: up to 12 months after treatment
Studying the different parameters of quality of life and their evolution over time.
up to 12 months after treatment
disorders of cognitive functions
Time Frame: up to 12 months after treatment
Studying the correlations between disorders of cognitive functions and parameters of quality of life and fatigue.
up to 12 months after treatment
biological disturbances
Time Frame: up to 9 months after treatment
Search for biological disturbances may be related to fatigue and cognitive disorders.
up to 9 months after treatment
Impact of anxiety and depression
Time Frame: up to 12 months after treatment
Assessing the impact of anxiety and depression at the waning of treatment
up to 12 months after treatment
List of symptoms
Time Frame: up to 12 months after treatment
Compare the list of symptoms considered important by the patient compared to those recorded in the medical record.
up to 12 months after treatment
Impact on the sexuality
Time Frame: up to 12 months after treatment
sess the impact on the sexuality of patients with the waning of treatment
up to 12 months after treatment
Effects of different antiangiogenic agents
Time Frame: up to 12 months after treatment
Compare the impact on quality of life and cognition side effects of different antiangiogenic agents used
up to 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Florence JOLY-LOBBEDEZ, PD, Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 14, 2011

First Posted (Estimate)

April 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COG-ANGIO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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