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An bidirectional, observational, multicenter cohort study of clinical features and prognosis in germ-line HRR-related gene mutations in epithelial ovarian cancer(AZALEA)

An bidirectional, observational, multicenter cohort study of clinical features and prognosis in germ-line HRR-related gene mutations in epithelial ovarian cancer(AZALEA)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060904
Enrollment
Unknown
Registered
2022-06-14
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Epithelial ovarian cancer

Interventions

Case series:None

Sponsors

The First Affiliated Hospital of University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Patients with EOC who were first diagnosed in each center were >18 years old; 2.All patients received standard staging, primary debulking surgery or interval debulking surgery, and EOC was confirmed by 2 or more chief pathologists before enrollment. 3.The time of diagnosis of enrolled patients should be followed up for at least 12 months for the last enrolled patient between January 1, 2018 and December 31, 2023; 4.All enrolled patients underwent genetic testing (including HRR-related genes); 5.Complete clinical data of patients: age at diagnosis of cancer, BMI, menopausal status, complications and family history;Tumor markers (CA125/CA199/HE4), blood routine examination, albumin and prealbumin, CRP, D-dimer and imaging data before treatment; Intraoperative ascites volume, SCS and DDS scores, postoperative pathological primary lesion size and location, lymph node size, location and metastasis, ER, PR, PAX8, Ki67, etc. 6.Whether Patients have a history of breast cancer and have been cured for nearly 2 years at the time of enrollment without treatment or recurrence; 7.For neoadjuvant chemotherapy patients, if CA125/CEA<25, gastrointestinal origin should be excluded by gastroenteroscopy; 8.At the time of study enrollment, patients who voluntarily signed informed consent forms approved by the Research Ethics Committee (EC) were informed of the potential risks, benefits, and discomforts of participating in the study after being appropriately informed of the nature of the study.

Exclusion criteria

Exclusion criteria: 1.There is no clear pathological diagnosis basis; 2.Patients who have participated in other biomedical studies or received experimental therapy within the past 30 days, unless approved by the investigator; 3.There are known contraindications to the upcoming first-line chemotherapy or second-line or multi-line chemotherapy; 4.Have a history of malignant tumors or co-existing other malignant tumors or multiple primary tumors (excluding breast cancer); 5.With HIV, hepatitis B, hepatitis C and other active infectious diseases or active rheumatic system diseases; 6.Ineligible for inclusion, such as severe or uncontrolled bacterial, fungal or viral infection, which may interfere with patients' participation in the study or evaluation of the study results; 7.The main information is not complete or the patients are lost to follow-up without reason during the study;

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactZhou Ying

The First Affiliated Hospital of University of Science and Technology of China

caddiezy@ustc.edu.cn+86 13865901025

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026