NCT01855191

Brief Summary

Introducing standardized data collection (SDC) for lung cancer patients to improve the performance of the prediction models.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
864

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Longer than P75 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

First Submitted

Initial submission to the registry

March 26, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

5.7 years

First QC Date

March 26, 2013

Last Update Submit

March 25, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Two-year survival rate

    24 months after RT

Secondary Outcomes (4)

  • Change in dyspnea

    during 24 months after RT

  • Change in cough

    During 24 months after RT

  • Change in dysphagia

    During 24 months after RT

  • Patient-rated generic quality of life

    During 24 months after RT

Study Arms (2)

Standard

Standard + saliva collection

Eligibility Criteria

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

All patients planned for curatively intended radiotherapy or postoperative radiotherapy.

You may qualify if:

  • All patients planned for curatively intended radiotherapy or postoperative radiotherapy
  • Recurrent disease

You may not qualify if:

  • All patients planned for palliative radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAASTRO clinic

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dirk De Ruysscher, MD., PhD.

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 26, 2013

First Posted

May 16, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

NL(1)