Clinical Research Directory

Multiplex Mutation Detection Using Mass Spectrometry in Bladder Cancer

Bladder cancer is a highly heterogeneous malignancy characterized by frequent genetic alterations that are closely associated with disease progression, recurrence risk, and treatment response. However, existing mutation detection approaches are often limited by high cost, complex workflows, or insufficient capacity for multiplex and low-frequency mutation analysis, which restricts their routine clinical application. The purpose of this study is to establish and clinically validate a multiplex mutation detection system for bladder cancer based on nucleic acid mass spectrometry. Using fresh tumor tissue and matched adjacent normal tissue samples collected from patients with bladder cancer, a targeted mutation panel comprising key functional mutations with demonstrated clinical relevance will be constructed. The matched normal tissues serve as germline references to enable accurate identification of somatic mutations. The analytical performance of the system, including sensitivity, specificity, and concordance with whole-genome sequencing, will be systematically evaluated. In addition, the clinical utility of the mutation panel in risk stratification and treatment decision support will be explored by comparing its predictive value with established clinical models and guideline-recommended tools. The ultimate goal is to develop a cost-effective, reproducible, and clinically applicable molecular testing strategy that can support precision diagnosis and individualized management of patients with bladder cancer.

CRUCIAL-R Study : Cruciferous Vegetables Dietary Regimen in NMIBC

Emerging evidence highlights the importance of nutrition in modulating cancer-related pathways, suggesting that specific dietary patterns and food choices may influence cancer risk. A protective role has been suggested for high consumption of vegetables, non-saturated fat oil (Mediterranean diet), fruits, and flavonoids \[10-13\]. In contrast, a diet rich in saturated fats and meat has been linked to an increased risk of BC \[14,15\]. Particularly, the consumption of vegetables of the Cruciferae family, such as broccoli, cauliflower, brussels sprouts, cabbage, kale, turnips, and others, has gathered attention for their potential protective effects due to their bioactive compounds: Isothiocyanates (ITCs). Dietary ITCs are a group of phytochemicals with multifaceted anticancer mechanisms primarily derived from cruciferous vegetables (CV) as glucosinolates and converted to ITCs by the action of the enzyme myrosinase \[16\]. Organic ITCs, particularly allyl isothiocyanate (AITC), benzyl isothiocyanate (BITC), phenethyl isothiocyanate (PEITC), and sulforaphane (SF), are among the most extensively studied cancer chemopreventive agents. Several mechanisms for ITCs in protection against carcinogenesis have been proposed, which include inhibition of carcinogen activation and promotion of detoxification, induction of cell cycle arrest and activation of apoptosis, inhibition of cancer cell invasion, modulation of the tumor microenvironment, inhibition of self-renewal of stem cells, rearrangement of energy metabolism and regulation of microbial homeostasis \[17-22\]. Aims Primary Objective • To evaluate the effect, in terms of recurrence-free survival (RFS) at 1 year, of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, or Very High-grade Non-Muscle Invasive Bladder Cancer treated with BCG (defined as the standard of care - SOC). Secondary Objectives * To evaluate the effect, in terms of time to recurrence, of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, and Very High-grade Non-Muscle Invasive Bladder Cancer. * To evaluate the effect, in terms of recurrence-free survival (RFS), of a dietary regimen characterized by high consumption of the Cruciferae family vegetables versus no dietary regimen in patients with Intermediate, High, and Very High-grade Non-Muscle Invasive Bladder Cancer with prior recurrence ≤1/yr and \<4 tumors (according to 2016 EORTC risk stratification for patients treated with maintenance BCG). * To evaluate the impact of high Cruciferous vegetable consumption on urinary ITC levels. * To evaluate the impact of high Cruciferous vegetable consumption on quality of life (QoL).

Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial

To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.

OUTCOMES of SIMULTANEOUS TRANSURETHRAL PROSTATE and BLADDER TUMOR RESECTION VERSUS TRANSURETHRAL BLADDER TUMOR RESECTION in BLADDER TUMOR with BLADDER PROSTATE HYPERPLASIA

The rationale of my study is that studies have shown that between 50% and 70% of patients treated with trans-urethral bladder tumor resection (TURBT) alone for NMIBC have recurrence with stage and grade progression in 10% to 15% and because of this theoretical danger of tumor cell implantation, many urologists avoid simultaneous trans-urethral prostate resection (TURP) and TURBT due to fear of implantation of tumor cells in the denuded areas of the resected prostate and prefer to perform a separate procedure for each pathological condition. However, others observed no deleterious effects of simultaneous TURBT and TURP. This unsettled controversy that has spanned almost 4 decades. This study will delineate guidelines for outcome of these procedures in terms of better prognosis for patients. OBJECTIVE: The objective of the study is to compare the outcome of simultaneous trans-urethral bladder tumor and prostate resection versus trans-urethral bladder tumor resection alone in bladder tumor with prostate hyperplasia in terms of in terms of recurrence of bladder tumor SUBJECTS AND METHODS Study Design: Randomized controlled trial Settings: Department of Urology, Jinnah Hospital and Allama Iqbal Medical College, Lahore. Study Population: Patients who will undergo TURP and TURBT at Jinnah Hospital, Lahore will be study population. Duration of study: 3 months after approval of synopsis. Sampling Technique: Non-Probability / consecutive Sampling Sample Size: Sample size calculated with 80 % power of study and 5 % level of significance Assumed recurrence rate of simultaneous trans-urethral bladder tumor resection with prostate resection (Group A) = 53.6% Assumed recurrence rate of trans-urethral bladder tumor resection alone (Group B) = 86.9% Required sample size of total of 60 patients (30 patients in each group) SAMPLE SELECTION: Inclusion Criteria * Males aged 40 - 65 year * First diagnosis of bladder neoplasm less than 4 cm, confined in urinary bladder * Prostate volume ≥ 40 and ≤ 80 ml with normal PSA level and obstructive voiding symptoms Exclusion Criteria * Patients with previous prostatic, urethral surgery and urinary bladder surgery like diverticulectomy, ureteric reimplant in urinary bladder * Patients with coagulopathy * Previous history of heart diseases * Diagnosis of prostate cancer * Urethral stenosis, previous pelvic irradiation, and neurogenic bladder. * Recurrent Bladder Tumor DATA COLLECTION PROCEDURE: The study involves 60 male patients diagnosed with bladder carcinoma, meeting inclusion criteria. Informed consent, emphasizing data confidentiality, will be obtained. Patients will be thoroughly examined at Jinnah Hospital Lahore. Preoperative assessment includes medical history, physical examination, digital rectal examination, PSA assay, and IPSS. Patients will be randomly assigned one of two treatments through a computer aided randomization. Patients will be followed with preoperative protocols, and undergo procedures under spinal anesthesia. In group A trans-urethral resection with a resectoscope is employed for both TURBT and TURP. In Group B TURBT, a wire loop electrode through the cystoscope removes bladder tumors in small pieces. TURP involves the resectoscope removing prostate tissue in small fragments, controlled by electrocautery. Post-surgery, complications were dealt with. Tissue fragments are sent to the lab for histopathological analysis. Follow-ups adhere to EAU guidelines, recording recurrence and UTI presence. Histopathology reports follow the 2004 WHO classification. The primary outcome recurrence rate will be noted in 3 months. All the information will be collected in a structured questionnaire.

Xpert Bladder Monitor: a Non-Invasive Follow-Up Tool for Detecting Relapse in High Grade or High Risk Bladder Cancer

Main objectives: Qualitative and quantitative monitoring of recurrences in patients with a previous diagnosis of high-grade bladder cancer at high risk of persistence/recurrence. Endpoints: Presence or absence of mRNA in urine with a dichotomous result; concordance between Xpert BM and histopathological examination Clinical relevance: reduces by half the number of (invasive) cystoscopies during follow-up. The non-invasive nature of the test could improve patient compliance with follow-up. Interventional study because it would reduce by half the number of cystoscopies during follow-up of bladder cancer which is considered the gold standard in the follow-up of this tumor. However, these markers are already CE validated and described in the European guidelines and for this reason the risk would be low.