Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer

NCT ID: NCT00005071

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1998-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Diagnostic procedures and treatment-planning systems may affect outcome in patients suspected of having lung cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of two types of diagnostic and treatment-planning systems in patients who are suspected of having lung cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES: I. Compare the survival rate of patients with suspected lung cancer when diagnosed and managed using the conventional locally based approach versus a new centralized system using a 2 stop diagnosis. II. Compare the resection rate in both diagnostic arms. III. Assess the quality of service given in both diagnostic arms.

OUTLINE: This is a randomized study. Patients present to a general practitioner where they are referred to the local chest clinic. Patients are seen by the chest physician and, if deemed eligible, are randomized between 2 diagnostic arms. Arm I (Conventional Locally Based Diagnosis): Patients undergo bronchoscopy and CT scan as appropriate, and then are discussed or referred by individual chest physicians, as is the current practice. The optimal period for diagnosis and discussion of management plans is 6 weeks. Arm II (Centralized 2 Stop Diagnosis): Patients undergo CT scan the following Monday morning. The consultant radiologist advises the most appropriate diagnostic test (e.g., bronchoscopy or percutaneous needle biopsy) to be done that same Monday. A tissue diagnosis is available Thursday morning for the multidisciplinary meeting attended by the chest physician, medical and clinical oncologists, and a surgeon, and the patient treatment plan is decided. Quality of life is assessed at baseline and at 6 weeks. Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 252-315 patients will be accrued for this study within 2 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

stage I non-small cell lung cancer stage II non-small cell lung cancer limited stage small cell lung cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

biopsy

Intervention Type PROCEDURE

bronchoscopy

Intervention Type PROCEDURE

computed tomography

Intervention Type PROCEDURE

quality-of-life assessment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

DISEASE CHARACTERISTICS: Possible diagnosis of lung cancer Fit enough for bronchoscopy and CT scan

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Not specified
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mary O'Brien, MD

Role: STUDY_CHAIR

Royal Marsden NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Marsden Hospital

Sutton, England, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMNHS-PATHWAY

Identifier Type: -

Identifier Source: secondary_id

EU-99039

Identifier Type: -

Identifier Source: secondary_id

CDR0000067676

Identifier Type: -

Identifier Source: org_study_id