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A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy

Identification of Markers of Resistance During Frontline Therapy and Maintenance

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06240598
Enrollment
10
Registered
2024-02-05
Start date
2024-01-26
Completion date
2027-01-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

stage III-IV, epithelial ovarian cancer, second Look Laparoscopy (SLL), 23-249

Brief summary

The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy. The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL. The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.

Interventions

PROCEDURESecond Look Laparoscopy

Second Look Laparoscopy (SLL)

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

This is a prospective study for biospecimen collection during standard of care procedures and during second look laparoscopy (SLL), which constitutes the only investigational procedure in this study.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients assigned female at birth≥ 18 years of age * Suspected or known stage III-IV epithelial ovarian cancer for which the patient has undergone, or is planned to undergo, attempted primary or interval debulking surgery * Homologous Recombination Deficiency testing should be planned to be completed prior to completion of initial platinum/taxane chemotherapy. HRD testing can be determined using : * Confirmation of deleterious Somatic or Germline BRCA mutation * CLIA certified test for HRD * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Exclusion criteria

* Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage gastrostomy tube * Patients receiving standard of care or investigational protocol directed treatment are eligible for this study, with the exception of protocol directed treatment which would prohibit the SLL surgery from being performed

Design outcomes

Primary

MeasureTime frameDescription
minimal residual disease (MRD) statusup to 12 weekswill be based on surgicopathological findings from multiple biopsies and peritoneal cytology obtained during the SLL procedure

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRachel Grisham, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026