Endometrial CancerACEmCaNCT05018195
Adipocytokines in Endometrial Cancer
A study testing Excise adipose tissue in people with Endometrial Cancer, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Excise adipose tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 29 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Profile of Adipocytokines in Patients With Endometrial Cancer: Focus on Various Types of Adipose Tissues
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Excise adipose tissue
- Keywords
- Obesity, Inflammation, Adiponectin, Endometrial cancer
- Medical subject headings
- Endometrial Neoplasms, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excise adipose tissueProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Excise adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipocytokines profile
Adipocytokines including leptin, adiponectin, visfatin, resistin, omentin, IL-1β, IL-6, IL-8, IL-10, TNF-α, IFNγ
Measured: During operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion29 Jul 2022 (estimated)
- Study completion29 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: women receive surgery for benign gynecologic lesions and women receive surgery for endometrial cancer
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018195
- Sponsor's protocol ID
- 202106074RIND
- Acronym
- ACEmCa
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share the adipocytokines profile raw data
Publications
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.
PubMed 30548482Lin 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.
PubMed 12914829Chen 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.
PubMed 16775581Lai 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.
PubMed 28254229Hopkins 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.
PubMed 27903152Rakotoarivelo 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.
PubMed 30341040
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of Adipocytokines in Patients With Endometrial Cancer: Focus on Various Types of Adipose Tissues
- ClinicalTrials.gov ID
- NCT05018195
- Acronym / sponsor ID
- ACEmCa / 202106074RIND
- Conditions
- Endometrial Cancer
- Keywords
- Obesity, Inflammation, Adiponectin, Endometrial cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 29 Jul 2022 (estimated)
- Study completion
- 29 Jul 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: women receive surgery for benign gynecologic lesions and women receive surgery for endometrial cancer
| Arm | Type | Receives |
|---|---|---|
| Benign | Active comparator | Procedure: Excise adipose tissueWomen 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. |
| Endometrial cancer | Experimental | Procedure: Excise adipose tissueWomen 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excise adipose tissuePerform 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 | Procedure or surgery | Benign, Endometrial cancer |
Primary outcome
Adipocytokines profile
Time frame: During operation
Adipocytokines including leptin, adiponectin, visfatin, resistin, omentin, IL-1β, IL-6, IL-8, IL-10, TNF-α, IFNγ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Results publication: PubMed 30548482Sung 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 publication: PubMed 12914829Lin 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 publication: PubMed 16775581Chen 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 publication: PubMed 28254229Lai 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 publication: PubMed 27903152Hopkins 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 publication: PubMed 30341040Rakotoarivelo 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.
- Individual participant dataSharing planned: Undecided. Share the adipocytokines profile raw data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Excise adipose tissue in people with Endometrial Cancer, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin Chi Tang (886-23123456 ext. 71964, stardom7370@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adipocytokines profile (time frame: During operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018195, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.