NCT01182155

Brief Summary

Patients treated with radiation therapy for lung tumors can experience inflammation after treatment. This study hopes to evaluate the use of breath analysis to evaluate changes in the composition of exhaled breath in patients undergoing radiotherapy. If changes can be detected, this may ultimately serve as biomarkers for identifying patients at highest risk for radiation-induced lung injury (radiation pneumonitis).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

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

August 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

August 12, 2010

Last Update Submit

June 30, 2016

Conditions

Lung CancerNon-Small Cell Lung CancerSmall Cell Lung Cancer

Keywords

Lung Cancer Non-Small Cell Cancer (NSCLC)Lung Cancer Small Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (1)

  • Pre and post-radiation FeNO (fraction of exhaled nitric oxide) measurements

    Every 3 months for 1 year

Secondary Outcomes (1)

  • Pre and post-radiation CO (carbon monoxide), CO2 (carbon dioxide), and N2O (nitrous oxide) measurements and feasibility as the fraction of patients unable to give a breath sample. Adverse events are not expected but any that appear related to the breath

    1 yr

Interventions

Exhaled Breath SamplingPROCEDURE

Standard of care

Also known as: breath gas analysis

Eligibility Criteria

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

Patients with lung tumors who are undergoing radiation therapy

You may qualify if:

  • Diagnosis of any type of lung tumor
  • Medical recommendation (independent of the study) that the patient undergo thoracic radiation therapy. Radiation therapy may be either fractionated or hypofractionated (i.e. radiosurgery)
  • Age \>= 18 years old
  • Any gender and any ethnic background will be recruited
  • Capable of giving written informed consent

You may not qualify if:

  • Inability of giving written informed consent
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Dr. Maximilian Diehn MD/PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 16, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

US(1)