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Establishment of a screening molecular marker and prognostic assessment system for female patients with sarcoma of the reproductive system: a single-center bi-directional observational study (YURIKA)

Establishment of a screening molecular marker and prognostic assessment system for female patients with sarcoma of the reproductive system: a single-center bi-directional observational study (YURIKA)

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059180
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma of the female reproductive system

Interventions

Genital sarcoma group:None
Uterine leiomyoma patients group:None

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for women with sarcoma of the reproductive system: (1) Patients with persistent/recurrent (including unstaged) sarcoma of the female reproductive system confirmed by pathology. Patients who are not staged (those who have not had hysterectomy or ovarian surgery) are also eligible and should be listed as ''not staged'' if the only histological (pathological) record of the disease is biopsy or curettage. If these patients have a record of metastatic disease, they should be assigned to the appropriate stage (III/IV). (2) The disease should be confirmed by a pathologist to meet one of the following conditions: 1) Uterus (tumor ICD-O code) : Leiomyosarcoma of uterus (8890/3); Epithelial leiomyosarcoma (8891/3); Myxoid leiomyosarcoma (8896/3); Low-grade endometrial stromal sarcoma (8931/3); Low-grade endometrial stromal sarcoma (8930/3); Undifferentiated sarcoma (8805/3); Rhabdomyosarcoma (8900/3); Carcinosarcoma (8980/3); Adenosarcoma (8933/3). 2) Ovarian (tumor ICD-O coding) : High-grade endometrioid stromal sarcoma (8930/3); Low-grade endometrioid stromal sarcoma (8931/3); Adenosarcoma (8933/3); Carcinosarcoma (8980/3); Fibrosarcoma (8810/3); Leiomyosarcoma (8890/3). 3) Fallopian tube (tumor ICD-O code) : Malignant Miller mixed tumor/carcinosarcoma (8950/3); Adenosarcoma (8933/3); Leiomyosarcoma (8890/3). 4) Broad ligament or other uterine ligament (tumor ICD-O code) : Adenosarcoma (8933/3); Leiomyosarcoma (8890/3). 5) Lower genital tract (tumor ICD-O code) : Liposarcoma (8850/3); Highly differentiated liposarcoma (8851/3); Dedifferentiated liposarcoma (8858/3); Pleomorphic liposarcoma (8854/3); Myxoid liposarcoma (8852/3); Leiomyosarcoma (8890/3); Epithelioid leiomyosarcoma (8891/3); Myxoid leiomyosarcoma (8896/3); Carcinosarcoma (8980/3); Adenosarcoma (8933/3). 6) Other rare sarcomas of the female reproductive system (tumor ICD-O code) : Embryonal rhabdomyosarcoma (8910/3); Alveolar rhabdomyosarcoma (8920/3); Pleomorphic rhabdomyosarcoma (8901/3); Vesicular soft tissue sarcoma (9581/3); Ewing's sarcoma (8364/3); Fibrosarcoma protuberans of the skin (8832/3); Fibrosarcoma protuberans of the skin (8832/1); Fibrosarcoma protuberans pigmentosa (8833/1); Kaposi's sarcoma (9140/3); Angiosarcoma (9120/3). 3) The first enrolled patient must be diagnosed after January 1, 2018, and the last enrolled patient must be diagnosed before December 31, 2028. (4) Complete clinical data and complete follow-up work. (5) Apply for a waiver of informed consent or voluntarily sign an informed consent approved by the Research Ethics Committee (EC) prior to enrollment in the study. 2. Inclusion criteria for patients with uterine leiomyoma: (1) Radiological or histopathological evaluation of newly diagnosed persistent/recurrent leiomyoma of the uterus ruled out the possibility of malignancy. (2) The first enrolled patient must be diagnosed after January 1, 2018, and the last enrolled patient must be diagnosed before December 31, 2028.

Exclusion criteria

Exclusion criteria: 1. Patients who have participated in other biomedical studies or received experimental treatments in the past 30 days, unless approved by the investigator; 2. Patients lost follow-up without reason during the study; 3. There is a severe or uncontrolled bacterial, fungal, or viral infection that, in the opinion of the principal investigator, may interfere with the patient's participation in the study or the evaluation of the results; 4. Any disease or medical condition that is unstable or may jeopardize patient safety and compliance with this study; 5. Previous history of malignant tumors or concurrent other malignant tumors or multiple primary tumors.

Design outcomes

Primary

MeasureTime frame
Lactate dehydrogenase;Carbohydrate antigen 125;Imaging manifestation;Pathological behavior;Overall survival;Progression-free survival;

Secondary

MeasureTime frame
Pathological behavior;Age of onset;

Countries

China

Contacts

Public ContactZhou Ying

The First Affiliated Hospital of University of Science and Technology of China

caddiezy@ustc.edu.cn+86 13865901025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026