NCT05183724

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 Nasopharyngeal carcinoma patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2019

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

February 16, 2019

Last Update Submit

January 4, 2022

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinomaovarian functionPregnancy outcomes

Outcome Measures

Primary Outcomes (1)

  • Premature Ovarian Failure (POF)

    Premature Ovarian Failure (POF) was defined as menopause before age 40 years. Menopause was defined as cessation of menstruation at least 1 year before the date of the survey in the absence of pregnancy, breastfeeding, continuous use of progestagens or other medication causing amenorrhea, or surgical removal of uterus and/ or ovaries.

    3 years after Radiotherapy

Secondary Outcomes (5)

  • Progress-Free Survival (PFS)

    3 years after Radiotherapy

  • Pregnancy and birth outcome

    Within 6 month of diagnosis, or 3-5years after Radiotherapy

  • Overall Survival (OS)

    3 years after Radiotherapy

  • Locoregional Relapse-Free Survival (LRFS)

    3 years after Radiotherapy

  • Distant Metastasis-Free Survival (DMFS)

    3 years after Radiotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female NPC patients (18 to 45 years old)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Haiqiang Mai, MD, PhD

CONTACT

86-20-8734-3643maihq@sysucc.org.cn

Qiuyan Chen, MD, PhD

CONTACT

86-20-8734-3380chenqy@sysucc.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 16, 2019

First Posted

January 11, 2022

Study Start

January 10, 2022

Primary Completion

January 10, 2025

Study Completion

January 10, 2026

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

CN(1)