- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04717349
Datainsamlingsstudie av pediatriska och ungdomsgynekologiska tillstånd
Background:
Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions.
Objective:
To create a database about child and teenage gynecologic conditions.
Eligibility:
Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members
Design:
Participants will be screened with a review of their medical records.
Participants may have a medical history and physical exam.
Participants will have blood drawn using a needle. The blood will be used for genetic tests.
Participants will have saliva collected. They will spit into a small plastic container. Or their spit will be absorbed from their mouth using a small sponge. The saliva will be used for genetic tests.
Participants may have samples collected from their vagina. A small cotton swab will be used to gather the samples. This procedure is optional.
If participants have a surgery related to their condition, a small tissue sample will be taken. It will be stored for future research.
Participants may complete optional surveys. These surveys ask about their physical and emotional health. They can choose not to answer any of the questions.
Researchers will collect medical data from participants standard tests. Such tests may include blood and urine tests, X-rays, nuclear medicine scans, and other tests. Data will also be collected from standard treatments they may receive.
Studieöversikt
Status
Detaljerad beskrivning
Study Description:
The overall purpose of Pediatric and Adolescent Gynecology (PAG) evaluations under this protocol is to gather information over time from a large group of patients with PAG conditions to help improve our understanding of these conditions. Our aim is to create a large database of PAG conditions in presentation and variety.
This study does not involve administration of investigational drugs, devices, or behavioral interventions. Participants receive standard clinical care independent of research participation.
Objectives:
Primary Objective:
- Recruit a diverse population of pediatric and adult subjects with known or suspected PAG disorders in order to collect data and specimen of typical and atypical presentations of PAG disorders.
- Create a large database of PAG conditions in presentation and variety.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Veronica Gomez-Lobo, M.D.
- Telefonnummer: (301) 435-7567
- E-post: veronica.gomez-lobo@nih.gov
Studieorter
-
-
Maryland
-
Bethesda, Maryland, Förenta staterna, 20892
- Rekrytering
- National Institutes of Health Clinical Center
-
Kontakt:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Telefonnummer: TTY8664111010 800-411-1222
- E-post: prpl@cc.nih.gov
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Pediatric and adolescent patients with gynecologic conditions and their family members that would provide clinical information related to the diagnosis of a proband.
Beskrivning
-
INCLUSION CRITERIA FOR PAG PATIENTS:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Participants with known or suspected pediatric and adolescent gynecologic conditions of any age are eligible for this protocol.
INCLUSION CRITERIA FOR PAG PATIENTS OF FAMILY MEMBERS:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: Relatives ages 18 years and older may be enrolled if clinically indicated for the diagnosis of a proband.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient, will exclude participation. Patients who are critically ill, unstable, or with severe organ failure that may affect/limit the evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded.
- Pregnant family members
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Family Members of PAG patients
Clinical evaluation of family members that would provide clinical information related to the diagnosis of a proband in future research. |
|
PAG patient
Pediatric and adolescent patients with gynecologic conditions. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruit a diverse population of pediatric and adult subjects
Tidsram: Ongoing
|
Recruit a diverse population of pediatric and adult subjects with known or suspected PAG disorders in order to collect evaluate the underlying natural history data and specimen of typical and atypical presentations of PAG disorders. |
Ongoing
|
|
Create a large database of PAG conditions
Tidsram: Ongoing
|
Create a large database of PAG conditions in presentation and variety. |
Ongoing
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Veronica Gomez-Lobo, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Manliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Gonadal sjukdomar
- Urogenitala abnormiteter
- Medfödda, ärftliga och neonatala sjukdomar och abnormiteter
- Medfödda abnormiteter
- Störningar i sexuell utveckling
Andra studie-ID-nummer
- 200126
- 20-CH-0126
Läkemedels- och apparatinformation, studiedokument
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