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Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire

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ClinicalTrials.gov Identifier: NCT03614689
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Geneplus-Beijing Co. Ltd.

Brief Summary:
To analyze the proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations; the ctDNA characteristics in patients with ovarian cancer; the correlation between the clonal status of mutations and therapy response; whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence; and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer.

Condition or disease
Ovarian Cancer

Detailed Description:
100 OC cases with available matched tumor DNA and plasma will be collected. All patients will be treated according to clinical guidelines, and receive circulating tumor DNA (ctDNA) liquid biopsy at the time of diagnosis, at mid treatment, at the end of treatment and during follow-up. The study will be ended when the patients have progressive disease (PD) or reach the longest follow-up time (2 years).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire
Actual Study Start Date : November 25, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer




Primary Outcome Measures :
  1. The ctDNA characteristics in patients with ovarian cancer , the correlation between the clonal status of mutations and therapy response and whether ctDNA detection can be used to predict the risk of ovarian cancer recurrence. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. The proportion of hereditary tumors in ovarian cancer patients in China, as well as the spectrum of variations and the characteristics of immune repertoire before and after treatment in patients with ovarian cancer. [ Time Frame: 1 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with previously untreated Ovarian Cancer.
Criteria

Inclusion Criteria:

  • Patients who have not received treatment including radiotherapy, chemotherapy, and surgery.
  • Expected to achieve satisfactory tumor cytoreductive surgery.
  • Estimated lifetime is more than 3 months.
  • Understand the research plan and voluntarily participate in the study, sign the informed consent form.
  • Ability to collect specimens from each time point and provide corresponding clinical information.

Exclusion Criteria:

  • Patients who will receive new adjuvant therapy.
  • Patients who have other primary cancer.
  • Pregnant or breast-feeding woman.
  • Patients with severe mental illness.
  • Patients achieve unsatisfactory tumor cytoreductive surgery.
  • Patients who voluntarily withdraw for any reason.
  • Patients who cannot complete the research plan.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614689


Locations
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China, Hunan
Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University Recruiting
Changsha, Hunan, China
Contact: Jing Wang, MD    +86-18908482599    wangjing189@163.com   
China, Shaanxi
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China
Contact: Ruifang An, MD    +86-18991232090    anruifang@xjtu.edu.cn   
China, Sichuan
Sichuan Cancer Hospital Recruiting
Chengdu, Sichuan, China
Contact: Guonan Zhang, MD    +86-028-88192999    zhanggn@hotmail.com   
China, Xinjiang
Affiliated Cancer Hospital of Xinjiang Medical University Recruiting
Ürümqi, Xinjiang, China
Contact: Jianlin Yuan, MS    +86-0991-7968088    wxm@xjzlyy.com   
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Yang Xiang, MD    +86-010-69155635    xiangy@pumch.cn   
Peking University International Hospital Recruiting
Beijing, China
Contact: Yongjun Wang, MD    +86-010-69006666    wyongjunfkwc@sina.com   
Sponsors and Collaborators
Geneplus-Beijing Co. Ltd.
Peking Union Medical College Hospital

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Responsible Party: Geneplus-Beijing Co. Ltd.
ClinicalTrials.gov Identifier: NCT03614689     History of Changes
Other Study ID Numbers: RN2017090101
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neoplasm, Residual
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplastic Processes
Pathologic Processes