SEPT9 gene methylation was validated as a biomarker for colorectal cancer (CRC) for >10 years and available as the Epi proColon test as an aid in CRC detection for >6 years. It was proven to be an accurate, reliable, fast, and convenient molecular test. In this opportunistic screening study, we validated a further simplified SEPT9 gene methylation assay in 1031 subjects in Chinese hospitals. The sensitivity for CRC detection was 76.6% at a specificity of 95.9%, and the results showed a satisfactory detection rate for each CRC stage, including early stages. The new SEPT9 assay, with enhanced technical simplicity, convenience, and lower cost, did not differ in performance compared with Epi proColon 2.0, the commercialized SEPT9 assay. The CRC detection sensitivity was further enhanced when the assay was combined with carcinoembryonic antigen (sensitivity, 86.4%) or fecal immunochemical test (sensitivity, 94.4%), suggesting that the combined tests may be an effective option for future opportunistic screening. In brief, our study has validated a new SEPT9 assay and combined testing as an aid in cancer detection, providing a new approach for opportunistic CRC screening.
Introduction: Type 1 gastric neuroendocrine tumors (g-NETs) have a good prognosis but a high recurrence rate. Aim: To observe the clinical efficacy of the treatment of type 1 g-NETs with the Chinese herbal decoction SMLJ01. Materials and Methods: A prospective and retrospective, clinical, controlled observation was conducted in 4 Chinese centers from 2012 to 2019. Patients with type 1 g-NETs were nonrandomly divided into treatment and control groups after endoscopic treatment based on herbal treatment administered according to their wishes. The treatment group received oral SMLJ01, with follow-up every 6 to 12 months, while the control group received follow-up alone. Patient follow-up (via telephone) from 2012 to 2017 was mainly retrospective. All patients after 2017 were followed prospectively. The recurrence times and rates were compared after treatment for at least 6 months. Symptom improvements were evaluated in the treatment group. The follow-up ended on October 31, 2019. Results: During a median follow-up of 22 months (range: 2-86 months), the survival rate was 100%, and no metastases occurred. Twenty-one of the 82 treated patients (25.6%) had recurrence after a median of 22 months, and 22 of the 54 control patients (40.7%) had recurrence after a median of 8 months ( P = .063). The Kaplan-Meier curve analysis showed that the patients in the treatment group had a significantly longer median recurrence-free survival (RFS) time than those in the control group ( P = .001). The risk of recurrence in the treatment group was 0.38 relative to that in the control group (95% CI: 0.20-0.70). The symptom score of the patients after taking Chinese medicine was 19.5 (10.3, 28.0), which was significantly lower than before treatment (31.5 (19.3, 38.0)). The difference was statistically significant ( P < .01). Conclusion: SMLJ01, with the effects of soothing the liver, strengthening the spleen, increasing acid and harmonizing the stomach, may help reduce the recurrence rate, relieve symptoms and prolong the recurrence time in patients with type 1 g-NETs and is worthy of evaluation with further randomized research with large sample sizes and longer follow-up periods.
Objective: To propose a scoring system based on laryngoscopic characteristics for the differential diagnosis of benign and malignant vocal cord leukoplakia. Design: Retrospective study. Setting: Tertiary hospitals Participants: Laryngoscopic images from 200 cases of vocal cord leukoplakia were retrospectively analyzed. The morphologies of vocal cord leukoplakia under laryngoscopy were evaluated by two laryngologists. Main outcome measures: The laryngoscopic signs of benign and malignant vocal cord leukoplakia were compared, and statistically significant features were assigned and accumulated to establish the leukoplakia finding score (LFS). Results: A total of five indicators (size, thickness, texture, hyperemia, and anterior commissure involvement) associated with malignant vocal cord leukoplakia were included to construct the LFS, with a possible range of 0–10 points. The diagnosis of malignant vocal cord leukoplakia as a score of ≥6 points was the most efficient. The sensitivity, specificity, and accuracy of the LFS were 93.8%, 83.6%, and 86.0%, respectively. The consistency in the LFS obtained by different laryngologists was strong (kappa=0.809). Conclusion: This scoring system based on laryngoscopic characteristics has high diagnostic value for distinguishing benign and malignant vocal cord leukoplakia.
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