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

Gynecologic Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02166515
• Other study ID #: 001
• Secondary ID: fck001
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 10, 2014
• Last updated: June 17, 2014
• Start date: October 2013
• Est. completion date: October 2017

Study information

• Verified date: June 2014
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gynecologic Malignant Tumor
• Neoplasms

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Zhiqing, Liang	Shenzhen Huada Genomics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer	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.	4 years	No
Secondary	the difference between detection sensitivity	Comparing sensiitivity of the three kinds of samples on early detection of gynecologic malignancies	4 years	No