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NCT03944798 · ClinicalTrials.gov registry record · NA

Surveillance AFter Extremity Tumor surgerY

A NA study of Soft Tissue Sarcoma and Lung Metastases, sponsored by McMaster University.

Active
Registry status
NA
Development phase
310
Enrollment target
20
Study locations

NCT03944798 is a NA study of Soft Tissue Sarcoma and Lung Metastases that is active but no longer recruiting, run by McMaster University. The registered enrollment target is 310 participants, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (325% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT03944798, a NA study of Soft Tissue Sarcoma and Lung Metastases, is active but no longer recruiting, sponsored by McMaster University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
310 participants
Enrollment target
20
Study locations

Study Summary

Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. Using a 2X2 factorial design to maximize efficiency and reduce overall trial costs, the SAFETY trial randomized 310 extremity soft-tissue sarcoma (STS) patients to determine the effect of surveillance strategy on overall patient survival after surgery for a STS of the extremity by comparing the effectiveness of both surveillance frequency (every 3 vs. every 6 months) and imaging modality (CT scans vs. chest radiographs).

Interventions

  • OTHER Frequency: Every 3 Months
  • OTHER Frequency: Every 6 Months
  • OTHER Imaging Modality: Chest Radiograph (CXR)
  • OTHER Imaging Modality: Chest CT

Study Locations (20)

New York

  • Albany Medical Center - Albany
  • NYU Langone Orthopaedic Hospital/Perlmutter Cancer Center - New York
  • Montefiore Medical Center - The Bronx

Other

  • Hospital Universitario Austral - Buenos Aires
  • LKH - Universitätsklinikum Graz - Graz
  • Cliniques Universitaires Saint-Luc - Brussels

California

  • University of California Davis Medical Center - Sacramento

Connecticut

  • Hartford HealthCare - Hartford

Florida

  • University of Florida Health Shands Hospital - Gainesville

Illinois

  • UChicago Medicine - Chicago

Indiana

  • Parkview Cancer Institute - Fort Wayne

Iowa

  • Holden Comprehensive Cancer Center - Iowa City

Trial Details

FieldValue
Enrollment Target 310 participants
Start Date 2019-11-19
Est. Completion 2027-12
Phase NA

Sponsor

McMaster University

31 total trials

What the Registry Record Tells You About NCT03944798

The ClinicalTrials.gov registry entry for NCT03944798 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 310 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 73-participant average among 55 other Soft Tissue Sarcoma trials with a reported enrollment target (325% higher). The listed sponsor is McMaster University, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Soft Tissue Sarcoma appearing as the primary indexed condition, and to 4 interventions - of which Frequency: Every 3 Months is the first listed.

NCT03944798 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Other, California.

Frequently Asked Questions

What is clinical trial NCT03944798 about?

NCT03944798 is a clinical study titled "Surveillance AFter Extremity Tumor surgerY". Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patie...

What is the current status of trial NCT03944798?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 310 participants. The study started on 2019-11-19. Estimated completion is 2027-12.

What conditions does trial NCT03944798 study?

This clinical trial studies the following conditions: Soft Tissue Sarcoma, Lung Metastases.

What interventions are being tested in trial NCT03944798?

The interventions under investigation include: Frequency: Every 3 Months (OTHER), Frequency: Every 6 Months (OTHER), Imaging Modality: Chest Radiograph (CXR) (OTHER), Imaging Modality: Chest CT (OTHER).

Who is sponsoring clinical trial NCT03944798?

This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03944798 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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