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Adipocytokines in Endometrial Cancer (ACEmCa)

Primary Purpose

Endometrial Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Excise adipose tissue
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometrial Cancer focused on measuring Obesity, Inflammation, Adiponectin, Endometrial cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Benign

    Endometrial cancer

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2021
    Last Updated
    August 18, 2021
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05018195
    Brief Title
    Adipocytokines in Endometrial Cancer
    Acronym
    ACEmCa
    Official Title
    Profile of Adipocytokines in Patients With Endometrial Cancer: Focus on Various Types of Adipose Tissues
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2021 (Anticipated)
    Primary Completion Date
    July 29, 2022 (Anticipated)
    Study Completion Date
    July 29, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Besides lipid metabolism, adipose tissue plays import roles in regulation of hormones, adipokines, cytokines and immunocytes. Adipose tissue is now known as endocrine organ which to express and secrete a variety of bioactive peptides, known as adipokines. We will evaluate the difference various adipocytokines between visceral and subcutaneous adipose tissues between women with benign lesions and endometrial cancer. We will study the inter-individual differences in adipocytokines between two types of adipose tissues and their correlation with image quantification.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometrial Cancer
    Keywords
    Obesity, Inflammation, Adiponectin, Endometrial cancer

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups: women receive surgery for benign gynecologic lesions and women receive surgery for endometrial cancer
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Benign
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Endometrial cancer
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Excise adipose tissue
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Adipocytokines profile
    Description
    Adipocytokines including leptin, adiponectin, visfatin, resistin, omentin, IL-1β, IL-6, IL-8, IL-10, TNF-α, IFNγ
    Time Frame
    During operation

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women received gynecologic surgery
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chin Chi Tang
    Phone
    886-23123456
    Ext
    71964
    Email
    stardom7370@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yi Jou Tai
    Phone
    8869721653
    Email
    017363@ntuh.gov.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Share the adipocytokines profile raw data
    Citations:
    PubMed Identifier
    30548482
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    12914829
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    16775581
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    28254229
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27903152
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30341040
    Citation
    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.
    Results Reference
    result

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    Adipocytokines in Endometrial Cancer

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