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NCT05751837 · ClinicalTrials.gov registry record · Phase 1
Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal
A Phase 1 study of Malignancy and Abdominal Cancer, sponsored by Patrick Wagner, MD, FACS.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT05751837: Completed Phase 1 study of Malignancy and Abdominal Cancer, sponsored by Patrick Wagner, MD, FACS.
NCT05751837 is a Phase 1 study of Malignancy and Abdominal Cancer that has completed, run by Patrick Wagner, MD, FACS. The registered enrollment target is 10 participants, below the 12,586-participant average among 8 other Malignancy trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05751837, a Phase 1 study of Malignancy and Abdominal Cancer, has completed, sponsored by Patrick Wagner, MD, FACS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this research study is to determine whether a sterile bacteria wall chemical, called lipopolysaccharide (LPS), can be injected safely into abdominal tumors during routine laparoscopic surgery performed as a preliminary procedure in patients who will subsequently undergo a larger planned operation to remove abdominal tumors. The researchers will biopsy the tumor before injection and then again at the time of the larger operation to assess whether any effect of the treatment can be measured.
Primary Outcome
The number, nature and severity of adverse events as assessed by CTCAE v 4.0 will be determined in patients undergoing injection of bacterial-derived immunotherapeutic toll receptor agonist (LPS) instilled via direct injection into intra-abdominal tumors during laparoscopic surgery.
Conditions Studied
Interventions
- BIOLOGICAL Lipopolysaccharide
Study Locations (2)
Pennsylvania
- Allegheny Health Network Allegheny General Hospital - Pittsburgh
- Allegheny Health Network West Penn Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 1 |
What the finished NCT05751837 record still lists
NCT05751837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 12,586-participant average among 8 other Malignancy trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Malignancy appearing as the primary indexed condition, and to 1 intervention - of which Lipopolysaccharide is the first listed.
NCT05751837 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05751837 about?
NCT05751837 is a clinical study titled "Feasibility Study of Intra-Tumoral Lipopolysaccharide Immunotherapy for Intra-Abdominal". The purpose of this research study is to determine whether a sterile bacteria wall chemical, called lipopolysaccharide (LPS), can be injected safely into abdominal tumors during routine laparoscopic surgery performed as a preliminary procedure in patients who will subsequently undergo a larger plann...
What is the current status of trial NCT05751837?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-03-16. Estimated completion is 2024-05-30.
What conditions does trial NCT05751837 study?
This clinical trial studies the following conditions: Malignancy, Abdominal Cancer.
What interventions are being tested in trial NCT05751837?
The interventions under investigation include: Lipopolysaccharide (BIOLOGICAL).
Who is sponsoring clinical trial NCT05751837?
This trial is sponsored by Patrick Wagner, MD, FACS, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05751837 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05751837's enrollment target sits among peer trials
10 9th of 8 the lowest of 8 other Malignancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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