Identification and Characterization of Endometrial Cancer With Specific Tumor Markers in Serum and Endometrial Tissue

NCT03498924 | Completed

• 1 other identifier: STUDY17104
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrial cancer is the most common malignant tumor of the female genital tract in our means. The diagnosis is made by endometrial biopsy sampling with anatomopathological analysis which pinpoints the cell line and the level of cell differentiation. Its treatment is surgical with adjuvant treatment (chemotherapy or radiotherapy) besides, depending on the staging. Thus far, in the first diagnosis it is only request the tumor marker CA125 in serum, but there are studies that identify the HE4 protein in blood as a feasible marker for endometrial cancer. Furthermore, the staging changes the surgical and the adjuvant treatment: in its early stages, surgery is based on hysterectomy and double adnexectomy, however, in later stages it is necessary to add pelvic and paraaortic lymphadenectomy with the associated comorbidity. This makes extremely important that the preoperative diagnosis is accurate. The aim of this study is to identify and characterize the HE4, Ki67, p53 and other potential biomarkers in endometrial tissue in order to diagnose patients with disease only with a biopsy. Moreover, the investigators are searching for connections among these markers and prognostic factors such as grade of cell differentiation, cell line, lymphatic affectation, tumor stage or even features as survival or disease free survival.

Conditions

Endometrial Neoplasm Malignant

Keywords

tumor marker; HE4; CA125; staging; diagnosis; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of positive H-score of HE4.

  HE4 quantified in endometrial tissue is significantly higher in patients with endometrial cancer than in non-EC patients

  Two years

Secondary Outcomes (12)

• Concentration of HE4 in tissue correlates linearly with HE4 in serum.

  Two years

• Difference in preoperative serum CA125 levels in cases and controls.

  Two years

• Difference in preoperative serum HE4 levels in cases and controls.

  Two years

• Disease stages

  Two years

• Tissue tumor marker HE4

  Two years

Study Arms (2)

CASES

Patients with endometrial cancer

Diagnostic Test: Measure of biomarkers in serum and endometrial tissue

CONTROLS

Matched controls without neoplasm disease

Diagnostic Test: Measure of biomarkers in serum and endometrial tissue

Interventions

Measure of biomarkers in serum and endometrial tissue DIAGNOSTIC_TEST

Blood sample and endometrial sample

CASES; CONTROLS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Every patient who is treated in Hospital de Leon of endometrial disease between August 2017 and the end of the recruitment

You may qualify if:

• Female
• Of legal age (≥ 18 years)
• Wish to participate in the research study and sign consent forms voluntarily
• Patients diagnosed of endometrial cancer derived to hysterectomy

You may not qualify if:

• Patients that underwent surgery for other malignant pathologies, whether for ovarian carcinoma, cervical carcinoma or uterine sarcoma.

Sponsors & Collaborators

• Fundación Investigación Sanitaria en León: lead

Study Sites (1)

Tatiana Cuesta-Guardiola

León, 24080, Spain

Location

Related Publications (4)

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.

  PMID: 29313949 RESULT

• Creasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41. doi: 10.1002/1097-0142(19901015)60:8+3.0.co;2-8.

  PMID: 3652025 RESULT

• Li X, Gao Y, Tan M, Zhuang H, Gao J, Hu Z, Wang H, Zhu L, Liu J, Lin B. Expression of HE4 in Endometrial Cancer and Its Clinical Significance. Biomed Res Int. 2015;2015:437468. doi: 10.1155/2015/437468. Epub 2015 Oct 11.

  PMID: 26539494 RESULT

• Bignotti E, Ragnoli M, Zanotti L, Calza S, Falchetti M, Lonardi S, Bergamelli S, Bandiera E, Tassi RA, Romani C, Todeschini P, Odicino FE, Facchetti F, Pecorelli S, Ravaggi A. Diagnostic and prognostic impact of serum HE4 detection in endometrial carcinoma patients. Br J Cancer. 2011 Apr 26;104(9):1418-25. doi: 10.1038/bjc.2011.109. Epub 2011 Apr 5.

  PMID: 21468050 RESULT

Related Links

• Cancer Research UK. Uterine Cancer Statistics.
• Group, U.S. Cancer Statistics Working. United States Cancer Statistics: 1999-2014 Incidence and Mortality Web-based Report.

Biospecimen

Retention: SAMPLES WITH DNA

Serum and endometrial tissue sample of every patient

MeSH Terms

Conditions

Endometrial Neoplasms; Disease

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tatiana Cuesta-Guardiola, Medicine

  Hospital de Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: April 17, 2018
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: June 1, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)