NCT03931356

Brief Summary

assess the consequences of low doses of radiation delivered by the volumetric radiotherapy, on the respiratory capacity of patients treated for bronchopulmonary carcinoma, by a follow up of functional respiratory exploration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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 14, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

2.7 years

First QC Date

April 26, 2019

Last Update Submit

February 27, 2023

Conditions

Cancer, LungRadiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

  • diffusion capacity

    diminution of 20% or more of the diffusion capacity at 3 months

    3 months

Interventions

Pulmonary function testsOTHER

analysis of lung volume and diffusion capacity

Eligibility Criteria

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

patient with bronchopulmonary carcinoma treated by radio(chimio)therapy alone

You may qualify if:

  • age \>18 years
  • bronchopulmonary carcinoma histological proved
  • OMS 0-2
  • indication of radio(chimio)therapy alone approved by multidisciplinary comitee
  • non opposition formular completed

You may not qualify if:

  • SBRT indication
  • history of thoracic surgery or irradiation
  • unstable disease
  • oxygenotherapy dependance
  • severe chronic bronchitis
  • collagen disease
  • pregnancy
  • contraception refusal
  • refusal or incapacity to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest (Morvan)

Brest, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

April 26, 2019

First Posted

April 30, 2019

Study Start

January 14, 2019

Primary Completion

September 24, 2021

Study Completion

October 15, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

Locations

FR(1)