NCT05755893

Brief Summary

The goal of this observational study is to clarify the significance of TB, PDC, DR, MELF, and immunohistochemical expression of those infiltrative patterns in patients with endometrial carcinomas (EC). The main questions it aims to answer are:

  1. 1.What is the relationship between TB, PDC, DR, MELF, and other clinicopathological features of patients with endometrial carcinomas (EC)?
  2. 2.What is the association of TB, PDC, DR, and MELF patterns with disease-free survival and overall survival?
  3. 3.Will the evaluation of the immunohistochemical expression of P53 in the TB, PDC, DR, and MELF patterns be important?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

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

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

February 23, 2023

Last Update Submit

March 11, 2023

Conditions

Endometrial Cancer

Keywords

endometrial cancertumor buddingmicrocystic, elongated, fragmented pattern invasionp53prognosis

Outcome Measures

Primary Outcomes (1)

  • Unusual infiltrative patterns and their IHC expression P35

    Presence or absence of Tumor budding, microcystic elongated fragmented pattern, desmoplastic reaction and poorly differentiated clusters

    2 years

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endometrial cancer patients

You may qualify if:

  • Histologically proven Endometrial cancer specimens.
  • underwent total abdominal hysterectomy, with myometrial invasion.

You may not qualify if:

  • Endometrial biopsies
  • hysterectomy specimens diagnosed with different pathological lesions rather than EC.
  • Specimens with prior chemotherapy or radiotherapy.
  • specimens without myometrial invasion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Karamitopoulou E. Role of epithelial-mesenchymal transition in pancreatic ductal adenocarcinoma: is tumor budding the missing link? Front Oncol. 2013 Sep 17;3:221. doi: 10.3389/fonc.2013.00221.

    PMID: 24062980BACKGROUND

  • Stewart CJ, Little L. Immunophenotypic features of MELF pattern invasion in endometrial adenocarcinoma: evidence for epithelial-mesenchymal transition. Histopathology. 2009 Jul;55(1):91-101. doi: 10.1111/j.1365-2559.2009.03327.x.

    PMID: 19614771BACKGROUND

  • Park JY, Hong DG, Chong GO, Park JY. Tumor Budding is a Valuable Diagnostic Parameter in Prediction of Disease Progression of Endometrial Endometrioid Carcinoma. Pathol Oncol Res. 2019 Apr;25(2):723-730. doi: 10.1007/s12253-018-0554-x. Epub 2019 Jan 2.

    PMID: 30604272BACKGROUND

  • Kobel M, Ronnett BM, Singh N, Soslow RA, Gilks CB, McCluggage WG. Interpretation of P53 Immunohistochemistry in Endometrial Carcinomas: Toward Increased Reproducibility. Int J Gynecol Pathol. 2019 Jan;38 Suppl 1(Iss 1 Suppl 1):S123-S131. doi: 10.1097/PGP.0000000000000488.

    PMID: 29517499BACKGROUND

  • Yamamoto M, Kaizaki Y, Kogami A, Hara T, Sakai Y, Tsuchida T. Prognostic significance of tumor budding, poorly differentiated cluster, and desmoplastic reaction in endometrioid endometrial carcinomas. J Obstet Gynaecol Res. 2021 Nov;47(11):3958-3967. doi: 10.1111/jog.14997. Epub 2021 Aug 26.

    PMID: 34448279BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

marina A adly, demonstrator

CONTACT

+201205546657Marina.14223910@med.aun.edu.eg

Etmad H yassin, professor

CONTACT

+201006816696etemad_yassin@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2025

Study Completion

August 1, 2025

Last Updated

March 14, 2023

Record last verified: 2023-03