Southern Medical University
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
NCT Number: NCT06287788
The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
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All sexes
Observational
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Nasopharyngeal carcinoma (NPC) is particularly prevalent in southern China. Radiation-induced oropharyngeal mucositis is one of the most common acute toxicities in patients with NPC receiving radiotherapy. Swallowing-induced breakthrough pain is a prominent clinical challenge for radiation-induced oropharyngeal mucositis, which has a great impact on patients' quality of life and treatment outcomes. Nonetheless, no particularly effective therapeutic methods or medication are available currently, thus making timely and accurate prediction, identifying high-risk patients, and providing appropriate interventions are critical in reducing or delaying the occurrence of severe oropharyngeal mucositis. It has been found that the performance of the predictive models for severe oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in NPC. The investigators defined a delineation method based on the mucosal areas of radiation-induced injury resulting in swallowing-induced breakthrough pain in locally advanced NPC, and our preliminary results demonstrated that the predictive model exhibited better overall performance. Therefore, the investigators aimed to conduct a prospective, multicenter, observational study to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
Time frame: Through study completion, up to 3 years
The area under the ROC (receiver operating characteristic) curve (AUC) of the predictive model
Time frame: Through study completion, up to 3 years
To obtained these metrics, true positive (TP), false positive (FP), true negative (TN), and false negative (FN) were calculated from the confusion matrix.
Sensitivity = TP/(TP + FN) Specificity = TN/(TN + FP) Accuracy = (TP+TN)/(Σ Total population) Positive Predictive value (PPV) = TP/(TP + FP) Negative Predictive value (NPV) = TN/(TN + FN) F1 score = 2TP/(2TP + FP + FN)
Time frame: Through study completion, up to 3 years
The importance of variables included in the predictive model was measure, and those with a higher value indicating a greater contribution to the model's classification accuracy were viewed as the important predictors.
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
The Prediction of a Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis in Patients With Nasopharyngeal Carcinoma: an Observational Study
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