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The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.

NCT05902390UNKNOWNNAINTERVENTIONAL

Summary

This study is an exploratory study based on the previous study " A prospective, multicenter, randomized, parallel arm-controlled, superiority clinical study to evaluate the role of hydrogel spacer in reducing rectal radiation dose in cervical cancer radiation therapy", in which additional follow up study on the subjects of the previous study were conducted. Subjects (6 subjects in Phase I; 100 subjects in Phase II, 50 in the test group and 50 in the control group) who completed the pre-study will be enrolled in this study if they are willing to participate in the long-term follow-up by signing the informed consent form.

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

106

Start Date

2023-06-01

Completion Date

2024-05-01

Study Type

INTERVENTIONAL

Official Title

A Prospective, Multicenter, Exploratory Clinical Study to Evaluate the Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.

Interventions

hydrogel spacer

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* Karnofsky score ≥ 70. Subjects aged ≥ 18 years and ≤ 75 years. Subjects must be able to cooperate in completing the entire study. The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.

No contraindications to CT scanning. Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form

Exclusion Criteria:

* Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.) Subjects with other primary malignancies Subjects with contraindications to radiotherapy, as determined by the investigators Subjects with injection site infections. Subjects who are allergic to the ingredients of the device. Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators Persons with severe mental illness, cognitive impairment and thinking disorders.

Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening Pregnant or lactating women or those who plan to get pregnant within the last six months Subjects who cannot be followed up as prescribed by the doctor Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen

Outcome Measures

Primary Outcomes

The stability of the hydrogel spacer

In order to verify the stability of the hydrogel spacer, this test will be based on MRI T2-weighed images.

Time frame: Through study completion, an average of 12 months

Scores from Quality of Life Questionnaire-Core 30 Rating (QLQ-C30)

European Organization for Research on Treatment of Cancer (EORTC) QLQ-C30 is a comprehensive survey instrument designed to assesses the disease-specific aspects of cervical cancer and its therapies. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.