NCT00601146

Brief Summary

This research study is being done because patients with a history of chest radiation treatment for Hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. The risk appears to be further increased among patients with a smoking history. Currently, the practice is to recommend annual low-dose chest CT scans in survivors of Hodgkin's disease who have received prior chest radiation treatment and who have at least a moderate smoking history. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner.

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 not_applicable lung-cancer

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable lung-cancer

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

November 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2016

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

4.1 years

First QC Date

January 15, 2008

Results QC Date

January 19, 2016

Last Update Submit

January 9, 2020

Conditions

Keywords

Hodgkin's diseaseCT scan

Outcome Measures

Primary Outcomes (1)

  • To Prospectively Collect Data on Chest CT Screening for Patients at Increase Lung-cancer Risk After Hodgkin's Disease.

    In this study, patients will under annual low-dose chest CT screening. The total number of lung cancer detected through the screening will be recorded

    3 years

Study Arms (1)

Low-dose Chest CT screening

EXPERIMENTAL

Annual low-dose Chest CT screening

Procedure: chest computed tomography scan

Interventions

Once a year for three years

Also known as: CT scan
Low-dose Chest CT screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or longer from initial Hodgkin's disease diagnosis
  • Current age 18 or older
  • Received mediastinal irradiation and/or alkylating-agent based chemotherapy
  • Smoking history of 10-pack years or more, or current smoker
  • Pre-approval from the participant's insurance company for the CT study

You may not qualify if:

  • Patients with a history of lung cancer
  • Currently receiving treatment for another cancer diagnosis
  • Known diagnosis of any metastatic cancer
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsHodgkin Disease

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title
Andrea Ng
Organization
DFCI

Study Officials

  • Andrea K. Ng, MD

    Dana-Farber Cancer Institute/Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Single arm study of low-dose Chest CT screening for long-term Hodgkin lymphoma survivors
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 25, 2008

Study Start

November 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2019

Last Updated

January 21, 2020

Results First Posted

February 17, 2016

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations