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Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

4. januar 2022 opdateret af: Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Nasopharyngealt karcinom

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

602

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Haiqiang Mai, MD, PhD
Telefonnummer: 86-20-8734-3643
E-mail: maihq@sysucc.org.cn

Undersøgelse Kontakt Backup

Navn: Qiuyan Chen, MD, PhD
Telefonnummer: 86-20-8734-3380
E-mail: chenqy@sysucc.org.cn

Studiesteder

Kina
- Guangdong
  - Guangzhou, Guangdong, Kina, 510060
    - Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
    - Kontakt:
      
      Haiqiang Mai, MD,PhD
      
      Telefonnummer: 862087343380 86-20-8734-3643
      
      E-mail: maihq@mail.sysu.edu.cn
    - Kontakt:
      
      Qiuyan Chen, MD, PhD
      
      Telefonnummer: 862087343380 86-20-8734-3380
      
      E-mail: chenqy@sysucc.org.cn
    - Ledende efterforsker:
      
      Haiqiang Mai
    - Ledende efterforsker:
      
      Qiuyan Chen
    - Underforsker:
      
      Shanshan Guo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Female NPC patients (18 to 45 years old)

Beskrivelse

Inclusion Criteria:

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 Criteria:

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Premature Ovarian Failure (POF) Tidsramme: 3 years after Radiotherapy	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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Progress-Free Survival (PFS) Tidsramme: 3 years after Radiotherapy	Progress-free survival is calculated from the date of registration to the date of the first progress at any site.	3 years after Radiotherapy
Pregnancy and birth outcome Tidsramme: Within 6 month of diagnosis, or 3-5years after Radiotherapy	The pregnancy history and pregnancy outcome of female Nasopharyngeal carcinoma (NPC) patients before diagnosis of NPC would be investigate Within 6 months of diagnosis. The pregnancy events and birth outcome of female NPC patients after diagnosis of NPC would be investigate among 3 to 5years after Radiotherapy.	Within 6 month of diagnosis, or 3-5years after Radiotherapy
Overall Survival (OS) Tidsramme: 3 years after Radiotherapy	The Overall Survival (OS) was defined as the duration from the date of registration assignment to the date of death from any cause or censored at the date of the last follow-up.	3 years after Radiotherapy
Locoregional Relapse-Free Survival (LRFS) Tidsramme: 3 years after Radiotherapy	The Locoregional Relapse-Free Survival (LRFS) is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit	3 years after Radiotherapy
Distant Metastasis-Free Survival (DMFS) Tidsramme: 3 years after Radiotherapy	The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit.	3 years after Radiotherapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

10. januar 2022

Primær færdiggørelse (Forventet)

10. januar 2025

Studieafslutning (Forventet)

10. januar 2026

Datoer for studieregistrering

Først indsendt

16. februar 2019

Først indsendt, der opfyldte QC-kriterier

4. januar 2022

Først opslået (Faktiske)

11. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)