N/A
N=100
Adipocytokines in Endometrial Cancer
Endometrial Cancer · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04697264 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Correlation Between Circulating Levels of These Markers and Demographic Characteristics. — 39; 42; 11; 8 Participants — p=0.026
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Blood and tissue sample collection from patients (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Surrey
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Circulating Levels of These Markers and Demographic Characteristics. |
39; 42; 11; 8; 15; 17 | 0.026 sig |
| PRIMARY Correlation Between Circulating Levels of These Markers (Day 0) and Cancer Characteristics in the Study Population, Using Linear Regresion. |
23; 13; 14; 41; 9; 36 | 0.033 sig |
| PRIMARY The Difference in Circulating Plasma Levels of Adiponectin Between Study and Control Patients |
5.9; 11 | <0.0001 sig |
| PRIMARY The Difference in Circulating Plasma Levels of Leptin, IGF1 and IGF2 Between Study and Control Patients. |
61.2; 41.9; 5.8; 7.8; 17.3; 19.3 | >0.05 |
| PRIMARY The Difference in Circulating Plasma Levels of IL6 and TNFα Between Study and Control Patients. |
17.3; 19.3; 118.8; 418.8 | <0.05 sig |
| PRIMARY Correlation Between the Markers and Study Patients' Obesity Status |
32.1 | >0.05 |
| PRIMARY Correlation Between the Markers and Control Patients' Obesity Status |
26.6 | 0.004 sig |
| SECONDARY Changes in Adiponectin Levels Before (Day 0) and After Surgery in the Study Population (at 6 Months). |
2.59; 2.26 | 0.0007 sig |
| SECONDARY Changes in Leptin, IGF1 and IGF2 Levels Before (Day 0) and After Surgery in the Study Population (at 6 Months). |
5.42; 5.51; 2.59; 2.94; 3.93; 4.85 | >0.05 |
| SECONDARY Changes in IL6 and TNFα Levels Before (Day 0) and After Surgery in the Study Population (at 6 Months). |
2.84; 3.01; 3.70; 3.62 | — |
| SECONDARY Expression of These Biomarkers and Their Receptors in Endometrial Cancer Tissue and Adipose Tissue |
116.6; 10165.2; 3.15; 0.839; 1.689; 1.741 | <0.0001 sig |
| SECONDARY Expression of These Biomarkers and Their Receptors in Endometrial Cancer Tissue and Lymph Nodal Tissue |
19.18; 653.235; 0.69; 1.37; 1.35; 10.10 | 0.0002 sig |
| SECONDARY Correlation Between Circulating Adiponectin Levels and Their Expression in Endometrial Tissue. |
5.76 | >0.05 |
| SECONDARY Correlation Between Circulating Leptin, IGF1 and IGF2 Levels and Their Expression in Endometrial Tissue. |
57.99; 5.73; 16.35 | >0.05 |
| SECONDARY Correlation Between Circulating IL6 and TNF Levels and Their Expression in Endometrial Tissue. |
31.71; 57.13 | >0.05 |
Summary
The number of women diagnosed with uterine cancer continues to rise each year. Since the early 1990s, there has been almost 55% rise in the United Kingdom (UK). 34% of endometrial cancer can be attributed to obesity. In the obese state, the function of adipose tissue deteriorates resulting in a state of chronic inflammation. Adipocytokine-related signalling pathways promote cancer development by causing inflammation, cell proliferation, DNA damage and by inhibiting apoptosis. The investigators postulate that adipocytokines levels are significantly different in uterine cancer patients of different weight categories and different grade/stage/ type of tumour.
Any woman attending the hospital with endometrial cancer and receiving treatment here will be invited to participate in the study. Consent will be sought to obtain 30mls (2 1/2 tablespoons) of venous blood at the time of surgery, on day 1 post-surgery and 3/6 months post-surgery during routine follow-up to check biomarker (adiponectin, leptin, tumour necrosis factor alpha, interleukin-6, Insulin-like growth factors 1 and 2) levels to see if the markers can be used to assess response to treatment. The investigators will also get consent to collect tissue - adipose tissue (after surgery) and uterine cancer tissue and lymph nodes (after histo-pathological evaluation) to assess for biomarkers. The investigators will also obtain blood samples from patients undergoing chemotherapy for advanced stage endometrial. All tissues procured will be anonymised and analysed at the oncology laboratory, Leggett building, University of Surrey and later correlated with patients' medical data as well as with tumour grade, stage and type. The investigators will also use archival tissue blocks stored at the same laboratory for analysis (previously consented for use in research). These are anonymised tissue and there is no link to patients' data.
The aim would be to ultimately find immuno-stimulatory/ suppressive biomarkers in order to develop novel diagnostic/ prognostic tools.
Eligibility Criteria
Inclusion Criteria
- Women diagnosed with endometrial cancer
- Age 18 or above
- Of sound mind so they can give informed consent
- Historical tissue sample/ blocks from previous cases in the laboratory in the University of Surrey, also be used if appropriate consent is in place.
Exclusion Criteria
- Under 18yrs age
- Unable to give consent /denies consent
Data sourced from ClinicalTrials.gov (NCT04697264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.