- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02166515
The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor
As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. In recent years, the incidence of cervical cancer, especially in young women significantly increased; ovarian cancer, although the incidence of malignant tumors in the female reproductive system ranked second, but its mortality rate already in the first place; and the morbidity and mortality of endometrial cancer is also rising.
The key to gynecologic malignancies is how to early diagnose and treat. With the advancement of science and technology, such as molecular biology techniques widely used in the medical field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for linkage analysis for gynecological malignancies possible. Therefore, the investigators intend to find specific mutations to provide a new early screening approach for gynecological malignancies, which in later result in early diagnosis and specific treatment for gynecological malignant tumors.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Chongqing
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Chongqing, Chongqing, Kina, 400038
- Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Female aging from 16 to 75-year old;
- Preoperative diagnosis of gynecologic malignancies;
- Have the ability to comply with Research programs;
- Voluntarily participate in the study and signed an informed consent form
Exclusion Criteria:
- The cases do not meet the inclusion criteria should be removed from,indicating the reason for excluding.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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experiment group
patients with cervical cancer, endometrial cancers or ovary cancer
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control group
postmenopausal women with benign tumor
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer
Tidsramme: 4 years
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We expect to found spcific DNA mutation in the species (peripheral blood, liquid Pap smear and cancer tissue) from cervical cancer, endometrial cancers and ovary.
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4 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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the difference between detection sensitivity
Tidsramme: 4 years
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Comparing sensiitivity of the three kinds of samples on early detection of gynecologic malignancies
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4 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)
- fck001 (Registry Identifier: ZLiang)
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Kliniske forsøg med Gynecologic Malignant Tumor
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Comenius UniversityRekruttering
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Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRekrutteringSolid tumor | Solid tumor, voksen | Solid tumor, uspecificeret, voksenForenede Stater, Puerto Rico
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National Health Research Institutes, TaiwanNational Cheng-Kung University HospitalRekruttering
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Elpiscience Biopharma, Ltd.Shanghai Junshi Bioscience Co., Ltd.AfsluttetNeoplasmer | Solid tumor | Ondartet tumorKina
-
RemeGen Co., Ltd.AfsluttetMetastatisk fast tumor | Lokalt avanceret solid tumor | Ikke-operabel fast tumorAustralien
-
Avelos Therapeutics Inc.RekrutteringSolid tumor | Solid tumorkræft | Solid tumor, voksen | Solid tumor, uspecificeret, voksen | Tumor, fast | Solid tumor i avanceret scene | Faste tumorer, der er ildfast til standardterapiKorea, Republikken