FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma, FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, Stage IA1 Endometrial Cancer FIGO 2023, Stage IA2 Endometrial Cancer FIGO 2023
Conditions
Brief summary
This study evaluates whether isolated tumor cells in the first lymph nodes near the tumor can tell researchers something important about the future of patients with a certain type of endometrial (uterine) cancer.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate whether the likelihood of disease recurrence differs between a prospective cohort of patients with low-risk endometrial cancer with ITC and an historical cohort with negative SLNs. OUTLINE: This is an observational study. Patients undergo tissue sample collection and have their medical records reviewed on study.
Interventions
OTHERNon-Interventional Study
Non-Interventional Study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Low-risk endometrial cancer, defined as endometrioid, grade 1 or 2, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA (FIGO 2023 stages IA1 and IA2), without substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. Patients with focal LVSI (\< 5 vessels involved) will be included. * Complete surgical staging, including pelvic sentinel lymph node (SLN) biopsy per National Comprehensive Cancer Network (NCCN) guidelines and ultrastaging. * Extent of disease in SLN: ITC (defined as tumor cell aggregates ≤ 0.2 mm or \< 200 cells) * No adjuvant treatment after surgery * Research consent provided.
Exclusion criteria
* Prior neoadjuvant chemotherapy. * Planning to receive adjuvant treatment. * Presence of synchronous cancer (excluding non-melanoma skin cancer). * Extent of disease in SLN: micrometastasis (\> 0.2 to ≤ 2.0 mm) or macrometastasis (\> 2.0 mm). * Presence of substantial/extensive LVSI (≥ 5 vessels involved) at final pathology. * Prior invasive cancer diagnosis within 5 years of study entry (excluding non-melanoma skin cancer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival (RFS) | Up to 5 years | RFS is defined as the length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. (Recurrence may be vaginal, hematogenous, lymphatic, or peritoneal.) RFS will be measured from the date of surgery to the date of recurrence, death, or last disease evaluation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-vaginal RFS | Up to 5 years | Non-vaginal RFS is defined as the interval from the date of surgery to the date of the first of the following events: non-vaginal recurrence or death due to any cause. |
| Overall Survival (OS) | Up to 5 years | Overall survival is defined as the time from surgery to death due to any cause. |
Countries
Austria, Brazil, Canada, France, Germany, Israel, Italy, Spain, Switzerland, United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORGretchen E. Glaser, MD
Mayo Clinic in Rochester
Outcome results
None listed