Status:
NOT_YET_RECRUITING
Ovarian Function of Nasopharyngeal Carcinoma Women Survivors
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
FEMALE
18-45 years
Brief Summary
This is an observational cohort study aimed to explore the fertility concerns, fertility preservation strategies, fertility status (pregnancy and Ovarian Failure) and birth outcome among young woman N...
Detailed Description
The purpose of this study was to explore the effects of radiotherapy and chemotherapy on ovarian function and pregnancy outcome after treatment in female survivors of non-metastatic nasopharyngeal car...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis
- Age between 18-45, female
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .
- Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
- No history of infertility.
- No history of hysterectomy or bilateral ovariectomy.
- Patient have signed on the informed consent, and well understood the objective and procedure of this study
Exclusion
- Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
- Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
- Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
- Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
- Patients with severe, uncontrolled disease or infections.
- Refuse or fail to sign the informed consent .
- Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 10 2026
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT05183724
Start Date
January 10 2022
End Date
January 10 2026
Last Update
January 11 2022
Active Locations (1)
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1
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060