NCT03455907

Brief Summary

Self-administered questionnaire survey to determine the presence or absence of joint pain during bevacizumab treatment for lung, ovarian, colorectal cancers. The principal end-point is the frequency of arthralgia after 6 months of treatment with Bevacizumab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

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

January 3, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

February 28, 2018

Last Update Submit

April 29, 2026

Conditions

Keywords

Bevacizumab

Outcome Measures

Primary Outcomes (1)

  • Frequency of arthralgia

    Frequency of joint manifestations of any grade according to the CTCAE (Common Terminology Criteria for Adverse Events) scale version 4.0 observed between the start of bevacizumab treatment and 6 months of treatment.

    At 6 months

Secondary Outcomes (2)

  • correlation between global cancer response and occurrence of arthralgia

    baseline, at 3 months, at 6 months

  • auto questionnaire specific to the study

    Baseline at 3 months, at 6 months

Study Arms (1)

Patients

patients with ovarian, colorectal or bronchopulmonary cancer receiving Bevacizumab

Eligibility Criteria

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

Patients treated with Bevacizumab for Lung, ovarian or colorectal cancers.

You may qualify if:

  • Patient with ovarian, colorectal or lung cancer receiving bevacizumab therapy
  • Male or female (aged ≥18 years old)
  • Performance Status (PS) between 0 and 2
  • Expected life\> 3 months
  • Ability to answer a self-questionnaire
  • Obtaining the non-opposition of patient participation

You may not qualify if:

  • Pregnant or lactating woman
  • Rapid evolution of neoplastic pathology
  • Major cognitive disorders that do not allow filling of the self-questionnaire
  • Impossibility to submit to medical monitoring for social, psychological or geographical reasons
  • Patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Oscar Lambret

Lille, France

Location

Hôpital Huriez. CHRU

Lille, France

Location

Related Publications (1)

  • Vauleon E, Behal H, Lebellec L, Desbarbieux R, Baldacci S, Simon N, Pannier D, Vieillard MH, Turpin A. Does bevacizumab increase joint pain in patients with cancer? Results of the prospective observational BEVARTHRALGIA study. Cancer Chemother Pharmacol. 2021 Apr;87(4):533-541. doi: 10.1007/s00280-020-04226-6. Epub 2021 Jan 12.

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-Hélène Viellard, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

January 3, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations