Nasopharyngeal CarcinomaNCT05183724
Ovarian Function of Nasopharyngeal Carcinoma Women Survivors
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 602 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 10 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
Study population: Female NPC patients (18 to 45 years old)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Haiqiang Mai, MD,PhD, 86-20-8734-3643 ext. 862087343380, maihq@mail.sysu.edu.cn
Qiuyan Chen, MD, PhD, 86-20-8734-3380 ext. 862087343380, chenqy@sysucc.org.cn
About this study
Official title: 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.
Read the 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 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
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, ovarian function, Pregnancy outcomes
- Medical subject headings
- Nasopharyngeal Carcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after Radiotherapy
Secondary outcomes (5)
Progress-Free Survival (PFS)
Progress-free survival is calculated from the date of registration to the date of the first progress at any site.
Measured: 3 years after Radiotherapy
Pregnancy and birth outcome
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.
Measured: Within 6 month of diagnosis, or 3-5years after Radiotherapy
Overall Survival (OS)
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.
Measured: 3 years after Radiotherapy
Locoregional Relapse-Free Survival (LRFS)
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
Measured: 3 years after Radiotherapy
Distant Metastasis-Free Survival (DMFS)
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.
Measured: 3 years after Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start10 Jan 2022 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183724
- Sponsor's protocol ID
- Ovarian Function of NPC
- Status last verified
- Jan 2022
- First submitted
- 16 Feb 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Radiotherapy and Chemotherapy on Ovarian Function and Post-treatment Pregnancy Outcomes in Women With Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT05183724
- Acronym / sponsor ID
- Ovarian Function of NPC
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Carcinoma, ovarian function, Pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Female NPC patients (18 to 45 years old)
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Premature Ovarian Failure (POF)
Time frame: 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.
5 secondary outcomes
Progress-Free Survival (PFS)
Time frame: 3 years after Radiotherapy
Pregnancy and birth outcome
Time frame: Within 6 month of diagnosis, or 3-5years after Radiotherapy
Overall Survival (OS)
Time frame: 3 years after Radiotherapy
Locoregional Relapse-Free Survival (LRFS)
Time frame: 3 years after Radiotherapy
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years after Radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiqiang Mai, MD, PhD (86-20-8734-3643, maihq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Ovarian Failure (POF) (time frame: 3 years after Radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.