Demographic FindingsNCT00928369
Clinical Characteristics of Patients Under the Age 21 Years Who Underwent Gynecological Surgery
An observational study of Demographic Findings and Presenting Symptoms on First Hospital Visit, run by Samsung Medical Center.
Trial summary
Young patients with adnexal lesions may have variable presenting symptoms. In this study, we reviewed the clinical characteristics of young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years. Read more about this study
- Who is it for?
- Ages 1 year to 20 years, women only
- Conditions the study is for
- Demographic Findings, Presenting Symptoms on First Hospital Visit, Preoperative Radiologic Findings
- How many people
- 494 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2009
- 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 1 year to 20 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The incidence of gynecologic surgery during the pediatric and adolescent period remains low. In this age group, the causes of gynecologic surgery were usually divided into three parts, congenital anomalies, genital traumas, and pathologic lesions of genital tract including uterine bady and cervix, ovaries, fallopian tubes, vagina, and vulva. Among these, adnexal masses generally have been the most common cause of gynecologic surgery in the pediatric and adolescent patients.
Who may be able to join
- Young women up to 20 years of age who took the gynecologic surgery due to adnexal lesions at the department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Korea from January, 1995 through March, 2009 were included.
Who cannot join
None listed.
About this study
Official title: Clinical Characteristics of Adnexal Masses in Korean Pediatric and Adolescent Patients Under the Age 21 Years
Young patients with adnexal lesions may have variable presenting symptoms. In this study, we reviewed the clinical characteristics of young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years.
Read the detailed description
The incidence of gynecologic surgery during the pediatric and adolescent period remains low. In this age group, the causes of gynecologic surgery were usually divided into three parts, congenital anomalies, genital traumas, and pathologic lesions of genital tract including uterine bady and cervix, ovaries, fallopian tubes, vagina, and vulva. Among these, adnexal masses generally have been the most common cause of gynecologic surgery in the pediatric and adolescent patients. Adnexal lesions span a spectrum of pathology from functional (non-neoplastic), benign to highly aggressive malignant neoplasms. The actual incidence of adnexal lesions in the young women is unknown; however, of the ovarian neoplasms operated on during childhood or adolescence, 10-30% are malignant. Therefore, early detection and adequate management of adnexal lesions are prerequisite for the life saving and future preservation of fertility potential. But until now, there have been limited studies regarding the clinical characteristics of patients with adnexal mass during this period, and most studies have been conducted with small numbers of patients. Therefore, more informations regarding the clinical characteristics of patients with adnexal lesions are very important for the early diagnosis and adequate management of the adnexal lesions in children and adolescents.
In this study, we reviewed the clinical characteristics of 494 young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demographic FindingsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- DooSeok Choi, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928369
- Sponsor's protocol ID
- 2009-04-053
- Status last verified
- Jun 2009
- First submitted
- 24 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics of Adnexal Masses in Korean Pediatric and Adolescent Patients Under the Age 21 Years
- ClinicalTrials.gov ID
- NCT00928369
- Acronym / sponsor ID
- 2009-04-053
- Conditions
- Demographic Findings, Presenting Symptoms on First Hospital Visit, Preoperative Radiologic Findings, Operation Method, Histologic Findings
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 25 Jun 2009 (estimated)
- 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.
Young patients with adnexal lesions may have variable presenting symptoms. In this study, we reviewed the clinical characteristics of young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years.
Detailed description
The incidence of gynecologic surgery during the pediatric and adolescent period remains low. In this age group, the causes of gynecologic surgery were usually divided into three parts, congenital anomalies, genital traumas, and pathologic lesions of genital tract including uterine bady and cervix, ovaries, fallopian tubes, vagina, and vulva. Among these, adnexal masses generally have been the most common cause of gynecologic surgery in the pediatric and adolescent patients. Adnexal lesions span a spectrum of pathology from functional (non-neoplastic), benign to highly aggressive malignant neoplasms. The actual incidence of adnexal lesions in the young women is unknown; however, of the ovarian neoplasms operated on during childhood or adolescence, 10-30% are malignant. Therefore, early detection and adequate management of adnexal lesions are prerequisite for the life saving and future preservation of fertility potential. But until now, there have been limited studies regarding the clinical characteristics of patients with adnexal mass during this period, and most studies have been conducted with small numbers of patients. Therefore, more informations regarding the clinical characteristics of patients with adnexal lesions are very important for the early diagnosis and adequate management of the adnexal lesions in children and adolescents.
In this study, we reviewed the clinical characteristics of 494 young Korean patients who took the operation in university hospital with adnexal lesions over the past 14 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The incidence of gynecologic surgery during the pediatric and adolescent period remains low. In this age group, the causes of gynecologic surgery were usually divided into three parts, congenital anomalies, genital traumas, and pathologic lesions of genital tract including uterine bady and cervix, ovaries, fallopian tubes, vagina, and vulva. Among these, adnexal masses generally have been the most common cause of gynecologic surgery in the pediatric and adolescent patients.
Key inclusion criteria (1 listed)
- Young women up to 20 years of age who took the gynecologic surgery due to adnexal lesions at the department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Korea from January, 1995 through March, 2009 were included.
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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.
DooSeok Choi, MD, PhD principal investigator
Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Demographic Findings and Presenting Symptoms on First Hospital Visit, run by Samsung Medical Center.
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 1 inclusion and 0 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 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 25 Jun 2009.