Endometrial Neoplasm Malignant Clinical Trial
Official title:
Prospective Identification and Characterization of Endometrial Cancer With Specific Tumor Markers in Serum and Endometrial Tissue Samples
NCT number | NCT03498924 |
Other study ID # | STUDY17104 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | June 1, 2019 |
Verified date | February 2020 |
Source | Fundación Investigación Sanitaria en León |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 1, 2019 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Patients that underwent surgery for other malignant pathologies, whether for ovarian carcinoma, cervical carcinoma or uterine sarcoma. |
Country | Name | City | State |
---|---|---|---|
Spain | Tatiana Cuesta-Guardiola | Leon |
Lead Sponsor | Collaborator |
---|---|
Fundación Investigación Sanitaria en León |
Spain,
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 carcinom — View Citation
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. — View Citation
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. Erratum in: Biomed Res Int. 2018 S — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Concentration of HE4 in tissue correlates linearly with HE4 in serum. | Comparison of tissue H-score with ppmol/L in serum | Two years | |
Secondary | Difference in preoperative serum CA125 levels in cases and controls. | Measured in terms of U/mL | Two years | |
Secondary | Difference in preoperative serum HE4 levels in cases and controls. | Measured in terms of ppmol/L | Two years | |
Secondary | Disease stages | FIGO stages: postsurgical classification drawn up to define the extent of spread of genital cancer | Two years | |
Secondary | Tissue tumor marker HE4 | H-score determination: Immunohistochemistry results can be evaluated by a semiquantitative approach used to assign an H-score (or "histo" score) to tumor samples. Cytoplasmic staining will be graded for intensity (0-negative, 1-weak, 2-moderate and 3-strong) and the percentage of positive cells was scored as 0 (0%), 1 (1-10%), 2 (11-50%) and 3 (51-100%). Single scale with scores 0-9 will be obtained by multiplying the intensity and the percentage staining score, and a total score will be calculated by grouping score 0 in total score 0, 1-3 in total score 1, 4-6 in total score 2 and 7-9 in total score 3. The assumption is that as higher is the score the level of cell differentiation would be minor. |
Two years | |
Secondary | Relation of the immunohistochemistry intensity in H-score with overall survival | HE4 biomarker measured with H-score in endometrial tissue, explained in outcome 5, in relation to length of time of survival | Through study completion, an average of 2 years | |
Secondary | Relation of the immunohistochemistry intensity in H-score with disease-free survival | HE4 biomarker measured with H-score in endometrial tissue, explained in outcome 5, in relation to length of time after primary treatment that the patient survives without any signs or symptoms of that cancer. | Through study completion, an average of 2 years | |
Secondary | Analysis of outcomes in relation to age | Age of patients is one of the known risk factors for EC, we are going to analysis the results of the study with this variable. As elder the relative risk is higher though there is no accurate cut-off point. | Two years | |
Secondary | Analysis of outcomes in relation to menopausal status | Menopausal status is determined by questionnaire during the preoperative consultant. It is another risk factor for EC, the postmenopausal status has higher relative risk than premenopausal status. | Two years | |
Secondary | Analysis of outcomes in relation to hypertension | Hypertension is diagnosed previously to surgery as Blood Pressure over 140/90 mm Hg in several measures. There is a known high relative risk of EC in patients diagnosed with hypertension. | Two years | |
Secondary | Analysis of outcomes in relation to diabetes | Diabetes is a disease previously diagnosed by high glucose levels in blood. There is a known high relative risk of EC in patients diagnosed with diabetes. | Two years | |
Secondary | Analysis of outcomes in relation to obesity | Obesity is defined as BMI >27 kg/m2. There is a known high relative risk of EC in patients diagnosed with obesity. | Two years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer
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N/A |