NCT06120309

Brief Summary

A validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (HGSOC) patients undergoing neoadjuvant chemotherapy (NACT) is still lacking. To address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (ONCPI) to improve predictive accuracy. We analyzed the clinicopathological characteristics of advanced HGSOC patients receiving platinum-based NACT. Blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. Omental hematoxylin and eosin (H\&E) stained slides were selected for the assessment of chemotherapy response score (CRS). Logistic regression analysis and Cox proportional hazards regression model were utilized to develop a prognostic index.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
465

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

November 2, 2023

Last Update Submit

November 2, 2023

Conditions

Ovarian CancerNeoadjuvant ChemotherapyPrognostic Cancer Model

Keywords

High-grade serous ovarian cancerNeoadjuvant chemotherapyPrognostic index

Outcome Measures

Primary Outcomes (1)

  • Response to platinum-based chemotherapy

    After NACT-IDS and postoperative adjuvant chemotherapy, treatment efficacy was assessed according to NCCN guidelines. For primary tumor, patients who relapsed 6 months or more after initial chemotherapy were termed platinum-sensitive. In contrast, patients whose disease recurred in less than 6 months were classified as platinum-resistant.

    At least 6 months after initial chemotherapy

Secondary Outcomes (2)

  • 3-year progression-free survival (PFS)

    3 years

  • 3-year overall survival (OS)

    3 years

Study Arms (1)

NACT Group

Diagnostic Test: CRS scoringDiagnostic Test: Routine blood laboratory testing before treatment

Interventions

CRS scoringDIAGNOSTIC_TEST

For pathological evaluation, the omental specimens resected during the IDS were stained with haematoxylin and eosin (H\&E) and reviewed independently by two gynecologic pathologists, both blinded to the clinical data and each other's results. The pathology slide obtained from omentum, usually the site with the most viable tumor, was selected for CRS assessment according to the three-tiered CRS system recommended by 2019 ESMO ovarian cancer guidelines

NACT Group
Routine blood laboratory testing before treatmentDIAGNOSTIC_TEST

The routine blood tests and tumor marker measurements, including CA125, HE4, and inflammation-related serum biomarkers including neutrophils, lymphocytes, monocytes, fibrinogen, and platelets, were conducted within three days before the first NACT.

NACT Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced HGSOC receiving platinum-based neoadjuvant chemotherapy (NACT) before interval debulking surgery (IDS) and postoperative adjuvant chemotherapy were enrolled

You may qualify if:

  • confirmed diagnosis of HGSOC by two experienced pathologists;
  • clinical stage III-IV according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) guideline;
  • Eastern Cooperative Oncology Group (ECGO) performance status of 0 to 1;
  • no prior anti-cancer therapy;
  • received ≥ 3 cycles of platinum-based NACT followed by IDS;
  • complete pretreatment blood test results and clinical and imaging data.

You may not qualify if:

  • other pathological types;
  • without NACT or IDS;
  • incomplete pretreatment data;
  • lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 520120, China

Location

Related Publications (5)

  • Hudry D, Becourt S, Scambia G, Fagotti A. Primary or Interval Debulking Surgery in Advanced Ovarian Cancer: a Personalized Decision-a Literature Review. Curr Oncol Rep. 2022 Dec;24(12):1661-1668. doi: 10.1007/s11912-022-01318-9. Epub 2022 Aug 15.

    PMID: 35969358RESULT

  • Colombo N, Sessa C, du Bois A, Ledermann J, McCluggage WG, McNeish I, Morice P, Pignata S, Ray-Coquard I, Vergote I, Baert T, Belaroussi I, Dashora A, Olbrecht S, Planchamp F, Querleu D; ESMO-ESGO Ovarian Cancer Consensus Conference Working Group. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent diseasedagger. Ann Oncol. 2019 May 1;30(5):672-705. doi: 10.1093/annonc/mdz062.

    PMID: 31046081RESULT

  • Liang WF, Wang LJ, Li H, Liu CH, Wu MF, Li J. The added value of CA125 normalization before interval debulking surgery to the chemotherapy response score for the prognostication of ovarian cancer patients receiving neoadjuvant chemotherapy for advanced disease. J Cancer. 2021 Jan 1;12(3):946-953. doi: 10.7150/jca.52711. eCollection 2021.

    PMID: 33403051RESULT

  • Li C, Wu J, Jiang L, Zhang L, Huang J, Tian Y, Zhao Y, Liu X, Xia L, E H, Gao P, Hou L, Yang M, Ma M, Su C, Zhang H, Chen H, She Y, Xie D, Luo Q, Chen C. The predictive value of inflammatory biomarkers for major pathological response in non-small cell lung cancer patients receiving neoadjuvant chemoimmunotherapy and its association with the immune-related tumor microenvironment: a multi-center study. Cancer Immunol Immunother. 2023 Mar;72(3):783-794. doi: 10.1007/s00262-022-03262-w. Epub 2022 Sep 3.

    PMID: 36056951RESULT

  • Rodolakis I, Pergialiotis V, Liontos M, Haidopoulos D, Loutradis D, Rodolakis A, Bamias A, Thomakos N. Chemotherapy Response Score in Ovarian Cancer Patients: An Overview of Its Clinical Utility. J Clin Med. 2023 Mar 10;12(6):2155. doi: 10.3390/jcm12062155.

    PMID: 36983157RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 31, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

CN(1)