An observational study in Endometrial Neoplasm Malignant, sponsored by Fundación Investigación Sanitaria en León. Completed at 1 site in Spain. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Fundación Investigación Sanitaria en León · Observational
Among 130 studies in Endometrial Neoplasms with a site in Spain — 53 open to participants now, 77 under way, 16 of them phase 3. Endometrial Neoplasms · Spain.
Among the 130 studies in Endometrial Neoplasms with a site in Spain, this one is the 13th largest by enrollment of the 14 observational ones, is one of 5 that started in 2017, is one of 14 observational ones, and was the 34th registered.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's enrollment of 80 is below the median of 179 across 331 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →53 of the 130 studies in Endometrial Neoplasms with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 359 Endometrial Neoplasms studies recruiting now, 269 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 27 take children under 18; 23 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →130 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 5 started in 2017.
Median enrollment 250 across the 115 interventional studies, 176 across the 14 observational. Of the 48 that completed or were terminated, 16 (33%) have results posted.
103 of 130 have an industry lead sponsor. The 10 most frequent:
Fundación Investigación Sanitaria en León is the lead sponsor of 4 studies on the registry; none are open to participants now.
Fundación Investigación Sanitaria en León has 1 study filed under Endometrial Neoplasms — fewer than ten, so there is no comparison to draw.
20 of the studies in Endometrial Neoplasms with a site in Spain that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04634877Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) | 2026-11-20 |
| NCT05173987Phase 3Merck Sharp & Dohme LLCStudy of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15) | 2027-05-27 |
| NCT07044336Phase 3AstraZenecaPuxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) | 2027-10-15 |
| NCT07838207Hospital Universitari Vall d'Hebron Research InstitutePrognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer | 2026-11-01 |
| NCT04585750PMV Pharmaceuticals, IncThe Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE) | 2026-12-15 |
Among the 130 studies in Endometrial Neoplasms with a site in Spain, from their registry updates:
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.
List of abbreviations:
The purpose of this study is:
Steps in the study:
Every patient who is treated in Hospital de Leon of endometrial disease between August 2017 and the end of the recruitment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with endometrial cancer
Diagnostic Test: Measure of biomarkers in serum and endometrial tissue
Matched controls without neoplasm disease
Diagnostic Test: Measure of biomarkers in serum and endometrial tissue
Blood sample and endometrial sample
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
Time frame: Two years
Concentration of HE4 in tissue correlates linearly with HE4 in serum.
Comparison of tissue H-score with ppmol/L in serum
Time frame: Two years
Difference in preoperative serum CA125 levels in cases and controls.
Measured in terms of U/mL
Time frame: Two years
Difference in preoperative serum HE4 levels in cases and controls.
Measured in terms of ppmol/L
Time frame: Two years
Disease stages
FIGO stages: postsurgical classification drawn up to define the extent of spread of genital cancer
Time frame: Two years
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.
Time frame: Two years
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
Time frame: Through study completion, an average of 2 years
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.
Time frame: Through study completion, an average of 2 years
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.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
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.
Time frame: Two years
Plan to share: No
Ran from Aug 2017 to primary completion in Aug 2018, 12 months.
Of 130 non-industry observational studies under Endometrial Neoplasms, half reached primary completion within 105 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 206. This study's 12 months is below that.
Counting every sponsor, half of 150 studies reached it within 105 months; a quarter within 32 and three quarters within 207.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Fundación Investigación Sanitaria en León