NCT04986189

Brief Summary

A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

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

May 26, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 4, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

May 26, 2021

Last Update Submit

November 1, 2024

Conditions

Hodgkin LymphomaLung Cancer

Keywords

screeninglow dose CT scan

Outcome Measures

Primary Outcomes (1)

  • Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study

    Feasibility outcome

    Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan

Secondary Outcomes (13)

  • Decisional conflict scores in those who receive the decision aid measured using the validated Decisional Conflict Scale (score 0-100 with higher score representing higher levels of decisional conflict)

    14 months

  • Preparedness for decision making in those who receive the decision aid using the validated Preparedness for Decision Making Scale (score 0-100 with higher score representing higher perceived levels of preparedness for decision making)

    4 months

  • Lung cancer screening knowledge pre and post receipt of the decision aid measured using a novel scale (score 0-16 with higher score representing high levels of knowledge about lung cancer screening)

    4 months

  • The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice

    6 and 12 months following CT scan

  • Anxiety levels pre and post screening measured using the State Trait Anxiety Inventory -6 validated scale (score 6-24 with higher score representing higher levels of anxiety)

    2 months post CT scan

  • +8 more secondary outcomes

Study Arms (1)

Invitation to have a low dose CT thorax

OTHER

All participants are invited to undergo a low dose CT thorax

Diagnostic Test: Low dose CT thorax

Interventions

Low dose CT thoraxDIAGNOSTIC_TEST

A low dose CT scan of the thorax to screen for lung cancer

Invitation to have a low dose CT thorax

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-80
  • year or more survivor of HL
  • Any of: a) treated with radiotherapy for HL with radiation dose to the lung b) an alkylating agent containing chemotherapy regimen known to increase lung cancer risk
  • Living within approximately 40 miles of The Christie Hospital

You may not qualify if:

  • Previous diagnoses of malignant neoplasm of trachea, bronchus, lung, thymus or pleura
  • A current diagnosis of metastatic cancer
  • Residents in nursing homes or housebound
  • Had a CT scan of the thorax within the last 12 months
  • Pregnant women
  • Unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

  • Broadbent R, Crosbie P, Armitage CJ, Taylor B, Tenant S, Mercer J, Radford J, Linton K. Pilot study of lung cancer screening for survivors of Hodgkin lymphoma. Haematologica. 2024 Oct 1;109(10):3305-3313. doi: 10.3324/haematol.2023.283287.

    PMID: 37981893DERIVED

MeSH Terms

Conditions

Hodgkin DiseaseLung Neoplasms

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2021

First Posted

August 2, 2021

Study Start

August 1, 2021

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

November 4, 2024

Record last verified: 2024-11

Locations

GB(1)