NCT04705649

Brief Summary

Endometrial cancer(EC) is the 4th most common cancer in women globally. Clinicians struggle to determine 'the best' treatment for endometrial cancers as they are very hard to tell apart under the microscope. Our BC team developed and validated a low-cost practical tool that can reliably distinguish ECs by molecular features. Molecular classification can inform women about the likelihood of their disease coming back as well as which treatments might work best for them or are not needed. Investigators are studying how this classifier can identify women at very low risk of disease recurrence in order to spare them toxic therapies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 14, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

January 7, 2021

Last Update Submit

August 9, 2023

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

  • Pelvic recurrence

    recurrent disease in the pelvis (including the vagina)

    every 6 months for the first 3 years

Secondary Outcomes (5)

  • Recurrence free survival

    every 6 months for the first 3 years

  • Overall survival

    every 6 months for the first 3 years

  • Sites of relapse

    every 6 months for the first 3 years

  • Patient Decisional Conflict Scale

    through study completion, an average of 3 years

  • Variation in treatment

    through study completion, an average of 3 years

Interventions

Treatment de-escalationOTHER

De-escalation from standard treatment based on molecular profile

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed endometrial carcinoma, with one of the following combinations of FIGO stage, grade, and LVI: Stage IA (not confined to polyp), grade 3 (with or without LVI), pN0 Stage IB, grade 1, 2 pNx/N0 with or without LVI Stage IB, grade 3 without LVI pN0 Stage II (microscopic), grade 1 or 2, pN0 and without substantial LVI Surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy). Pelvic LN assessment is required for grade 3 or stage II cancers. Para-aortic lymphadenectomy is not mandated.
  • Age ≥18 years
  • Eastern Cooperative Group (ECOG) performance status 0, 1 or 2.
  • Ability to understand and willing to sign a written informed consent document.

You may not qualify if:

  • Prior chemotherapy for endometrial cancer or previous pelvic radiation.
  • History of another invasive malignancy, except for non-melanoma skin cancers or tumors curatively treated with no evidence of disease for ≥ 5 years
  • Inability to be registered and receive treatment within 12 weeks of hysterectomy .
  • Abnormal p53 (p53abn) and/or mismatch repair deficiency (MMRd) on immunohistochemistry without pathogenic POLE mutation.
  • MELF (microcystic, elongated and fragmented (MELF)) pattern of invasion is excluded within p53wt/NSMP tumors, not POLEmut

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer - Vancouver Centre

Vancouver, British Columbia, V5Z 2E6, Canada

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gynaecologic Oncologist

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 12, 2021

Study Start

July 14, 2020

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

CA(1)