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Using Aspirin to Improve Immunological Features of Ovarian Tumors

StatusSuspended
PhaseEarly Phase 1
Started2021-11-02
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
critical
Recruitment suspended: Study drug is expiring. Will reopen when new drug is received.
Primary completion pushed: 2026-07 → 2026-11
2026-07-09
minor
Study Status, Contacts/Locations v21
Study sitescontacts updated at 1 of 4 sites
2026-03-31
minor
Study Status v20
Re-verified, no change to tracked fields
2026-01-07
minor
Study Status v19
Primary completion date2025-12→2026-07
2025-09-29
minor
Study Status v18
Re-verified, no change to tracked fields
Show 17 earlier versions
2025-06-11
minor
Study Status v17
Primary completion date2025-05→2025-12
Completion date2025-05→2026-12
2025-03-13
minor
Study Status v16
Re-verified, no change to tracked fields
2024-12-11
minor
Study Status, Contacts/Locations v15
Study sites3→4
2024-08-06
minor
2 amendments v13-v14
2 re-verifications since 2024-06-13, no change to tracked fields
2024-03-05
minor
Study Status, Contacts/Locations v12
Study sites2→3
2024-02-19
minor
Study Status v11
Primary completion date2025-03→2025-05
Completion date2025-03→2025-05
2024-02-13
minor
2 amendments v9-v10
2 re-verifications since 2023-09-18, no change to tracked fields
2023-04-11
minor
Study Status, Contacts/Locations v8
Study sites1→2
2023-04-05
notable
Suspended→Recruiting Study Status, Contacts/Locations v7
Trial statusSuspended→Recruiting
Reason stoppedStudy drug is expiring. Will reopen when new drug is received.→not stated
Study sitesdetails revised at 1 of 1 site
2023-03-16
minor
Study Status, Eligibility v6
Eligibility criteria+45 characters
[...] allopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2/3). All histologies including serous, endometrioid, clear cell [...]
2023-02-24
minor
Study Status v5
Start date2021-10-01→2021-11-02
2022-10-12
notable
Recruiting→Suspended Study Status, Contacts/Locations v4
Trial statusRecruiting→Suspended
Reason stoppednot stated→Study drug is expiring. Will reopen when new drug is received.
Study sitesdetails revised at 1 of 1 site
2022-09-30
minor
Study Status v3
Re-verified, no change to tracked fields
2021-12-13
minor
Study Status, Eligibility v2
Eligibility criteria+214 characters
Inclusion Criteria: Participants that are greater than or equal to 18 years of age For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French Histology confirmed, or clinical suspicion of, invasive epit [...] llopian tube, or peritoneal carcinoma. Must be grade 2 or 3. All Seroushistologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology [...] r coagulopathy within 6 months prior to enrollment of study ActiveUncontrolled diagnosis of refluxerosive esophagitis req [...] [...]
2021-10-15
minor
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v1
Eligibility criteriarevised
[...] e can be post-transfusion Estimated creatinine clearance of <> 30 mL/min, calculated using the formula Cockcroft-Gault [(1 [...]
Study sitescontacts updated at 1 of 1 site
2021-10-05
minor
Original filing
The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma
Trial Details
NCT Number NCT05080946
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: United States Department of Defense, Sharp
Conditions Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Enrollment 100 participants
Start Date 2021-11-02
Primary Completion 2026-11 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-15