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NCT04751409 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities
A Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 227
- Enrollment target
- 1
- Study location
NCT04751409: Recruiting Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04751409 is a Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 227 participants, above the 160-participant average among 4 other Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 trials with a reported enrollment target (42% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04751409, a Phase 2 study of Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 and Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 227 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.
Primary Outcome
Will be calculated as the area under the curve by obtaining patient-reported outcomes at 4 separate time points and then graphically calculating and comparing the area under the curve for each patient. The mean area under the curve of the Fear of Cancer Recurrence Inventory - Short Form will be estimated along with a 95% confidence interval within each study group.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Chest Radiography
- PROCEDURE Follow-Up
- PROCEDURE Imaging Technique
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2020-12-28 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT04751409 shows while recruiting
NCT04751409 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, above the 160-participant average among 4 other Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 trials with a reported enrollment target (42% higher).
The record links to 4 conditions, with Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT04751409 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04751409 about?
NCT04751409 is a clinical study titled "Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities". This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persis...
What is the current status of trial NCT04751409?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 227 participants. The study started on 2020-12-28. Estimated completion is 2027-12-31.
What conditions does trial NCT04751409 study?
This clinical trial studies the following conditions: Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8, Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8.
What interventions are being tested in trial NCT04751409?
The interventions under investigation include: Computed Tomography (PROCEDURE), Chest Radiography (PROCEDURE), Follow-Up (PROCEDURE), Imaging Technique (PROCEDURE).
Who is sponsoring clinical trial NCT04751409?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04751409 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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