Clinical trial NCT03614689: Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire
Official title: Assessment of the Minimal Residual Disease in Ovarian Cancer From Circulating Tumor DNA and Immune Repertoire
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2018-08-03
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with previously untreated Ovarian Cancer.

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.

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).

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 1 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
state: Hunan
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Ürümqi
country: China
facility: Affiliated Cancer Hospital of Xinjiang Medical University
state: Xinjiang
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University International Hospital
Study officials:
References: