The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02166515

Enrollment

200

Registered

2014-06-18

Start date

2013-10-31

Completion date

2017-10-31

Last updated

2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Malignant Tumor

Keywords

cervical cancer, ovarian cancer, endometrial cancer, high-throughput sequencing

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer	4 years	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.

Secondary

Measure	Time frame	Description
the difference between detection sensitivity	4 years	Comparing sensiitivity of the three kinds of samples on early detection of gynecologic malignancies

Countries

China

Outcome results