NCT07366242

Brief Summary

  • To compare DHODH protein expression in HGSC tissues from patients undergoing Primary Debulking Surgery (PDS - Chemo-naive) versus Interval Debulking Surgery (IDS - Post-NACT).
  • To evaluate the association between DHODH expression and the degree of chemotherapy response (using the Chemotherapy Response Score - CRS for NACT cases).
  • To determine the prognostic value of DHODH expression in predicting Platinum-Free Interval (PFI) ,Progression -Free Survival (PFS) and Overall Survival (OS) across both groups.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

January 10, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 10, 2026

Last Update Submit

January 16, 2026

Conditions

HGSOC

Outcome Measures

Primary Outcomes (1)

  • DHODH expression and patient survival

    To evaluate the prognostic impact of DHODH expression in high-grade serous ovarian carcinoma by assessing its correlation with survival outcomes (overall survival and/or progression-free survival) and comparing patients treated with neoadjuvant versus adjuvant chemotherapy.

    from diagnosis up to last follow up or death ( up to 96 months).

Study Arms (2)

Group A chemo naive and Group B neoadjuvant group

Group A (Chemo-naïve group) 36 Patients who underwent primary debulking surgery (PDS) followed by adjuvant platinum-based chemotherapy. Group B (Neoadjuvant group) 36 Patients who received 3-4 cycles of platinum-based neoadjuvant chemotherapy followed by interval debulking surgery (IDS).

Other: Immunohistochemical (IHC) assessment of DHODH expressionOther: No interventions as it is observational study

Group A (Chemo-naïve group) 36 Patients and Group B (neoadjuvant) group

Group A (Chemo-naïve group) 36 Patients who underwent primary debulking surgery (PDS) followed by adjuvant platinum-based chemotherapy. Group B (Neoadjuvant group) 36 Patients who received 3-4 cycles of platinum-based neoadjuvant chemotherapy followed by interval debulking surgery (IDS).

Other: Immunohistochemical (IHC) assessment of DHODH expressionOther: No interventions as it is observational study

Interventions

Immunohistochemical (IHC) assessment of DHODH expressionOTHER

Comparative analysis of DHODH expression in adjuvant and neoadjuvant groups and correlate its expression with clinical outcomes

Group A (Chemo-naïve group) 36 Patients and Group B (neoadjuvant) groupGroup A chemo naive and Group B neoadjuvant group
No interventions as it is observational studyOTHER

No interventions as itis observational study

Group A (Chemo-naïve group) 36 Patients and Group B (neoadjuvant) groupGroup A chemo naive and Group B neoadjuvant group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from patients diagnosed with high-grade serous ovarian carcinoma will be retrieved from the pathology archives

You may qualify if:

  • Histologically confirmed high-grade serous ovarian carcinoma
  • Availability of adequate FFPE tumor tissue
  • Known treatment modality (PDS or IDS)
  • Available clinical follow-up including platinum-free interval and survival data

You may not qualify if:

  • Non-serous histological subtypes
  • Low-grade serous carcinoma
  • Inadequate tissue for immunohistochemistry
  • Missing clinical or follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Interventions

Immunohistochemistry

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Central Study Contacts

heba ahmed mohamed, demonstrator

CONTACT

01151056041heba.ahmed17199d@gmail.com

dalia mohamed mohsen, Prof.Dr

CONTACT

01066189050daliabadary@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
demonstrator

Study Record Dates

First Submitted

January 10, 2026

First Posted

January 26, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)