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

NCT02166515 | Unknown DMC

• 2 other identifiers: 001fck001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Malignant Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• the difference between detection sensitivity

  4 years

Study Arms (2)

experiment group

patients with cervical cancer, endometrial cancers or ovary cancer

control group

postmenopausal women with benign tumor

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The experiment group are patients with cervical cancer, ovarian cancer or endometrial cancer.While the control group are volunteers on the basis of informed consent.

You may qualify if:

• 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

Sponsors & Collaborators

• Zhiqing, Liang: lead
• Shenzhen Huada Genomics Co., Ltd.: collaborator

Study Sites (1)

Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military

Chongqing, Chongqing Municipality, 400038, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The sample of blood, urine, cervical exfoliated cells and cancer tissue of patient should be used only in this research with informed consent. The remaining part will be Safekeeping.All information is strictly confidential.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Obstetrics and Gynaecology, Southwest Hospital

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: June 18, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

CN (1)