NCT01336231

Brief Summary

Longitudinal study nonrandomized, multicenter observational descriptive monitoring patients treated with anti-angiogenic for metastatic kidney cancer

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

4.7 years

First QC Date

April 12, 2011

Last Update Submit

July 20, 2016

Conditions

Metastatic Kidney Cancer

Keywords

quality of lifecognitive functionsantiangiogenic agentskidney cancermetastatic

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 12 months after treatment

Secondary Outcomes (7)

  • Parameters of quality of life

    up to 12 months after treatment

  • disorders of cognitive functions

    up to 12 months after treatment

  • biological disturbances

    up to 9 months after treatment

  • Impact of anxiety and depression

    up to 12 months after treatment

  • List of symptoms

    up to 12 months after treatment

  • +2 more secondary outcomes

Study Arms (1)

patients group

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre François BACLESSE

Caen, Calvados, 14076, France

Location

Centre Henri Becquerel

Rouen, Seine Maritime, 76000, France

Location

CHU

Rouen, Seine Maritime, 76038, France

Location

CHU

Strasbourg, 67091, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Hôpital Georges Pompidou

Paris, Île-de-France Region, 75908, France

Location

MeSH Terms

Conditions

Kidney NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Florence JOLY-LOBBEDEZ, PD

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 15, 2011

Study Start

October 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

July 21, 2016

Record last verified: 2016-07

Locations

FR(6)