NCT05018195

Brief Summary

Endometrial cancer incidence rates were increasing in the past two decades with a continuous rising trend in Taiwan. Uterine cancer was attributable to obesity based on their association with excess body weight in most epidemiological cohort studies. However, the prevalence of obesity was lower in Taiwan.Therefore, we will study if adipose tissues depots in different locations of body could reflect or correlate the pathogenesis of endometrial cancer.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

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

August 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

August 18, 2021

Last Update Submit

August 18, 2021

Conditions

Keywords

ObesityInflammationAdiponectinEndometrial cancer

Outcome Measures

Primary Outcomes (1)

  • Adipocytokines profile

    Adipocytokines including leptin, adiponectin, visfatin, resistin, omentin, IL-1β, IL-6, IL-8, IL-10, TNF-α, IFNγ

    During operation

Study Arms (2)

Benign

ACTIVE COMPARATOR

Women who receive surgery for benign lesions including leiomyoma, adenomyosis, or ovarian cysts. We will obtain one 5\*5 cm omental fat and one 3\*3 cm subcutaneous adipose tissue during surgery.

Procedure: Excise adipose tissue

Endometrial cancer

EXPERIMENTAL

Women who receive surgery(staging or cytoreductive surgery) for endometrial cancer. We will obtain one 5\*5 cm omental fat and one 3\*3 cm subcutaneous adipose tissue during surgery.

Procedure: Excise adipose tissue

Interventions

Perform partial omentectomy to obtain one 5\*5 cm omental fat and excise one 3\*3 cm subcutaneous adipose tissue( 2 finger width above the pubic symphysis) during surgery

BenignEndometrial cancer

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen received gynecologic surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women diagnosed with primary endometrial cancer and undergo surgery, with or without adjuvant therapy in our hospital (EmCa group); women received surgery for benign pelvic lesions in our hospital (control group)

You may not qualify if:

  • Women with an underlying malignancy or any concomitant malignancy, prior chemotherapy or radiation before diagnosis of endometrial cancer, history of autoimmune diseases or immunosuppressive agent use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Sung H, Siegel RL, Torre LA, Pearson-Stuttard J, Islami F, Fedewa SA, Goding Sauer A, Shuval K, Gapstur SM, Jacobs EJ, Giovannucci EL, Jemal A. Global patterns in excess body weight and the associated cancer burden. CA Cancer J Clin. 2019 Mar;69(2):88-112. doi: 10.3322/caac.21499. Epub 2018 Dec 12.

  • Lin YC, Yen LL, Chen SY, Kao MD, Tzeng MS, Huang PC, Pan WH. Prevalence of overweight and obesity and its associated factors: findings from National Nutrition and Health Survey in Taiwan, 1993-1996. Prev Med. 2003 Sep;37(3):233-41. doi: 10.1016/s0091-7435(03)00119-1.

  • Chen LJ, Fox KR, Haase A, Wang JM. Obesity, fitness and health in Taiwanese children and adolescents. Eur J Clin Nutr. 2006 Dec;60(12):1367-75. doi: 10.1038/sj.ejcn.1602466. Epub 2006 Jun 14.

  • Lai JC, Weng CS, Huang SM, Huang N, Chou YJ, Wang CC, Wang KL. Incidence and lifetime risk of uterine corpus cancer in Taiwanese women from 1991 to 2010. Taiwan J Obstet Gynecol. 2017 Feb;56(1):68-72. doi: 10.1016/j.tjog.2015.09.010.

  • Hopkins BD, Goncalves MD, Cantley LC. Obesity and Cancer Mechanisms: Cancer Metabolism. J Clin Oncol. 2016 Dec 10;34(35):4277-4283. doi: 10.1200/JCO.2016.67.9712. Epub 2016 Nov 7.

  • Rakotoarivelo V, Lacraz G, Mayhue M, Brown C, Rottembourg D, Fradette J, Ilangumaran S, Menendez A, Langlois MF, Ramanathan S. Corrigendum to "Inflammatory cytokine profiles in visceral and subcutaneous adipose tissues of obese patients undergoing bariatric surgery reveal lack of correlation with obesity or diabetes" EBioMedicine 30C (2018) 237-247. EBioMedicine. 2018 Nov;37:564-568. doi: 10.1016/j.ebiom.2018.10.025. Epub 2018 Oct 16. No abstract available.

MeSH Terms

Conditions

Endometrial NeoplasmsObesityInflammation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two groups: women receive surgery for benign gynecologic lesions and women receive surgery for endometrial cancer
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2021

First Posted

August 24, 2021

Study Start

September 1, 2021

Primary Completion

July 29, 2022

Study Completion

July 29, 2022

Last Updated

August 24, 2021

Record last verified: 2021-08