Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

NCT ID: NCT05183724

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

602 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-10

Study Completion Date

2026-01-10

Brief Summary

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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 Nasopharyngeal carcinoma patients.

Detailed Description

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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 carcinoma, so as to clarify the relationship between ovarian dysfunction after treatment and pregnancy outcome, as well as clarify the relationship between pregnancy after treatment and tumour progression.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis
2. Age between 18-45, female
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
4. 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) .
5. Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
6. No history of infertility.
7. No history of hysterectomy or bilateral ovariectomy.
8. Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria

1. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
2. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
3. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
4. Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
5. Patients with severe, uncontrolled disease or infections.
6. Refuse or fail to sign the informed consent .
7. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Hai-Qiang Mai,MD,PhD

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Haiqiang Mai, MD, PhD

Role: CONTACT

86-20-8734-3643

Qiuyan Chen, MD, PhD

Role: CONTACT

86-20-8734-3380

Facility Contacts

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Haiqiang Mai, MD,PhD

Role: primary

86-20-8734-3643 ext. 862087343380

Qiuyan Chen, MD, PhD

Role: backup

86-20-8734-3380 ext. 862087343380

Other Identifiers

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Ovarian Function of NPC

Identifier Type: -

Identifier Source: org_study_id

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