An interventional study of hydrogel spacer in Uterine Cervical Neoplasms, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
The purpose of this study is to evaluate the long-term benefit of hydrogel spacer when hydrogel is injected between the rectum and cervix in women undergoing radiation therapy.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 106 is close to the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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
The Subjects randomized to the treatment group underwent placement of hydrogel spacer.
Device: hydrogel spacer
The Subjects randomized to the control group did not receive injection of the hydrogel spacer.
Randomly assigned to either the treatment group, who were injected with hydrogel spacer, or the control group, who were not injected with hydrogel spacer.
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.
Time frame: through study completion, an average of 12 months
Scores from Quality of Life Core Questionnaire Cervix Cancer Module 24 (QLQ-CX24)
European Organization for Research on Treatment of Cancer (EORTC) QLQ-CX24 will be used to assess subjects' quality of life. EORTC QLQ-CX24 score from 0 to 100, higher scores indicate better quality of life or more symptoms.
Time frame: through study completion, an average of 12 months
Percentage of subjects with ≥2 grade chronic radiation rectal injury
The percentage of subjects in the treatment and control groups who had ≥ grade 2 chronic radiation rectal injury after radiation therapy will be calculated and compared between the groups.
Time frame: through study completion, an average of 12 months
Adverse events requiring special attention
The number of cases of adverse events requiring special attention related to radiation intestinal injury and the number of subjects having the above adverse events will be recorded in both the treatment and control groups.
Time frame: through study completion, an average of 12 months
The number of (serious) adverse events, (serious) device-related adverse events
The frequency (number of events) of occurrence of (serious) adverse events and device-related (serious) adverse events will be recorded for the entire study period.
Time frame: through study completion, an average of 12 months
Plan to share: Yes
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Peking Union Medical College Hospital