Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

Disease Progression

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Disease Attributes

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

BCG Vaccine

Abdelwahab R. Hashem, Msc

Ahmed M Harraz, MD

Ahmed Mosbah, MD

A prospective observational study to re-establish a new prognostic model for predicting the outcome in patients with non-muscle invasive bladder cancer (NMIBC) using the current recommendation regimen for intermediate and high risk groups and including all potential and highly prognostic factors.

Bladder urothelial carcinoma is the most common cancer of the urinary tract and is the 7th most common cancer in males and the 7th most common cancer in females. Most of newly diagnosed cases of urothelial cancer of the bladder are non-muscle invasive (NMIBC), and including stages Ta, T1, or Carcinoma in situ (CIS). The initial management is endoscopic resection, aiming at complete removal of all visible papillary lesions, and accurate staging of the bladder tumor. The future plan is determined based on the results of histopathological diagnosis and included either re-resection or adjuvant immunotherapy.

The incidence of recurrence and progression to muscle invasive disease after resection of NMIBC reaches up to 42 % and 21%, respectively, concluding that alternative treatments are urgently required. Therefore, the development of prognostic models is of ultimate importance to minimize long-term morbidity and improve the outcome. The most commonly used stratification systems are the European Organization for Research and Treatment of Cancer (EORTC) risk tables and the The Club Urologico Espanol de Tratamiento Oncologico (CUETO) scoring model. The EORTC risk tables have been constructed based on 2596 patients diagnosed with Ta/T1 urothelial bladder carcinoma. Nevertheless, there were low number of patients treated with BCG (7%), as well as immediate postoperative instillation of chemotherapy (\<10%); in addition, there was no second-look transurethral resection (re-TUR) of the bladder was performed. The CUETO scoring model has been built based on a retrospective analysis of 1,062 patients underwent TUR of bladder tumor followed by 6-month BCG maintenance therapy. Nevertheless, the study was limited by the relatively old grading systems, lack of re-TUR or immediate intravesical instillation, and inadequacy for determining the time of recurrence.

Pan et al have developed a prognostic nomogram from the retrospective analysis of 1366 patients with NMIBC classified according to the 2004 World Health Organization WHO/International Society of Urologic Pathology grading system. Similarly, this study was limited by the retrospective nature, lack of the current recommendations of immediate intravesical instillation, and lack of studying other different prognostic factors . Ali-El-Dein et al have constructed a nomogram for recurrence and progression based on a retrospective analysis of more than 1000 patients from a single institution. Nevertheless, there was heterogeneity on the adjuvant regimens, in addition, re-TUR were not performed in all patients.

Recently, Cambier et al have published their nomograms and risk stratification systems based on a data from 1812 patients with intermediate risk and high risk NMIBC with adjuvant BCG maintenance therapy 1-3 years. Although this study presents the first prognostic factor analysis in NMIBC patients receiving the currently recommended 1-3 yr of maintenance BCG, it has several limitations. There was no repeat transurethral resection in high risk patients during the study period. In addition, there was no central pathology review, and there was no data on upper tract status at time of recurrence or progression.

Although all previously mentioned nomograms have demonstrated significant ability for detecting the outcome after transurethral resection of bladder tumor. Neither of these papers has included any other biological markers that have been proven to improve the predictive ability. Recently, special emphasis has been focused on the relation between smoking with recurrence and progression of NMIBC. It has been shown that smoking not only increases the risk of disease recurrence and progression, but also Current and heavy long-term smokers seem to be at the greatest risk for both end points. In addition, Ogihara et al have shown that a positive smoking history was an independent predictor for NMIBC recurrence and refraining from smoking for 15 years or more reduced the risk of tumor recurrence in former smokers with regardless of the intensity or duration of smoking.

Inflammation in the tumor microenvironment plays a crucial role in the proliferation and survival of malignant cells through enhanced angiogenesis, invasion, and metastasis. The underlying mechanisms include recruitment of T lymphocytes, chemokines, activated cytokines, secretion of CRP, and neutrophilia . In a recent meta-analysis, Masson-Lecomte et al have shown that among different inflammatory predictors, serum levels of C-reactive protein (CRP), Neutrophil to lymphocyte ratio (NLR), and urinary and serum interleukin levels were the most prognostic factors for bladder cancer prognosis. Furthermore, Kamat et al have shown that a cytokine panel had the potential for identifying patients at risk of tumor recurrence during BCG treatment. In addition, interleukin IL-2 have been shown to be the most prognostic biomarker for response to BCG therapy.

In a recent meta-analysis including 15,215 patients, Martin-Doyle et al have shown that the highest impact risk factor was depth of invasion into lamina propria. In addition, lymphovascular invasion, associated carcinoma in situ, tumor size \> 3 cm, and older age were independent predictors for progression and cancer specific survival.

Currently, all publications investigating the outcome after treatment of NMIBC lack several factors including the re-staging TUR, maintenance BCG therapy, inclusion of other highly prognostic factors e.g. smoking, inflammatory biomarkers, depth of lamina invasion. Therefore, this protocol is constructed to combine all clinically affordable biomarkers into a prognostic model for predicting the outcome after NMIBC.

A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer Using Clinical Histopathological and Biological Markers

meta-analyses by contact the Prof. Ahmed Mosbah MD (Study Chair)

Outcome Measure by counting and cmparing number of patients surviving for two year without tumor recurrence or progression to muscle invasive bladder cancer

Outcome Measure by counting and comparing number of patients surviving for five year without tumor. Mortality cases will be counted if oncology is the cause of mortality

Outcome Measure by conting and comparing number of patients surviving for five year without tumor. Mortality cases will be counted if the cause of mortality is other than oncology

Mansoura University

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Antineoplastic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Nedaplatin

Radiotherapy is the main treatment strategy with an overall dose of over 75Gy.

The chemotherapy regimens included cisplatin (40 mg/m2) or nedaplatin (80 mg/m2) monotherapy or combined with paclitaxel (135 mg/m2) every three weeks during radiotherapy.

Treatment mainly composed of external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT) .

Yang Sun

This study aims to validate the value of tumor involvement features based on MRI in cervical cancer, facilitate the development of a more appropriate model for risk stratification, and help patients with varying risk profiles make appropriate decisions in treatment selection and follow-up plans.

Even with the development of advanced technology, the prognosis for CC patients who received radiotherapy is still an intractable problem. Almost 40% suffered disease recurrence among locally advanced patients after radiotherapy and the reported 5-year overall survival is 50-70%. The present FIGO staging is controversial in pre-treatment assessment, which is mainly based on physical examination. An ambiguous diagnosis leads to different treatment strategies and follow-up plans, which is associated with prognosis non-improvement. Incorporation of the tumor involvement features based on the MRI into pre-treatment assessment could standardize and improve the consistency and repeatability of diagnosis.

MRI-based Signatures for Survival Prediction in Cervical Cancer With Radiotherapy

A Prognostic Model Based on MRI for Cervical Cancer Patients Treated With Radiotherapy

the interval from diagnostic day to death or the last follow-up

the interval from diagnostic day to death, the last follow-up, or the onset of regional recurrence or distant metastasis

Fujian Cancer Hospital

Neoplasm Metastasis

Neoplastic Processes

The overall dose should be more than 75 Gy. patients received surgery should be excluded.

Radical RT consisted of external pelvic beam radiotherapy (EBRT) and individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT).Cisplatin-based concurrent chemoradiotherapy (CCRT) was recommended for CC patients unless for economic status, age consideration and patients' desires.

external pelvic beam radiotherapy (EBRT) followed by individualized high-dose-rate intracavitary brachytherapy (HDR-ICBT)

Yang Sun, PhD

This study aims to help to screen out appropriate cases for consolidation therapy and more intensive follow up.

Some cervical cancer patients experienced distant metastasis quickly after receiving complete radiotherapy and have a worse prognosis. However, there were few studies focused on these patients and with early distant metastasis. It is significant to predictive and screen out cervial cancer patients with a high risk of early metastasis for more comprehensive treatments and follow-up plans

A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy

A Novel Predictive Model and Risk Stratification for Early Metastasis in Cervical Cancer Patients After Radiotherapy

Early distant metastasis defines as metastasis occurrence between 3 -12 months after radiotherapy.

Adenocarcinoma

To develop the prognostic model, 302 cases of postoperative PDAC were included in the final analysis and divided into the training and validation cohort by stratified sampling with 7:3 ratio (The training cohort: n=212; The validation cohort: n=90).

Surgical resection of pancreatic cancer，including radical or palliative surgery

pancreatic cancer surgery

Tingbo Liang

The AJCC TNM staging system is the prevailing method in prognostic evaluation of pancreatic ductal adenocarcinoma (PDAC) at present , but it did not include factors such as the tumor immune microenvironment that are known to exert a profound impact on patients'clinical outcome. This study was aimed to develop a comprehensive and effective prognostic score model to predict prognosis and guide clinical management for postoperative PDAC patients.

A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma

Development and Validation of a New Prognostic Score Model Combining TNM Stage With Immune Risk Factors for Postoperative Pancreatic Ductal Adenocarcinoma

the number of months from the date of surgery to the date of the last follow-up visit or time of death.

the number of months from the date of surgery to the date of first confirmable recurrence or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)	NCT03121768	Oncology Bladder Cancer Superficial Bla... Recurrence Progression BCG		18 Years -	Mansoura University
MRI-based Signatures for Survival Prediction in Cervical Cancer With Radiotherapy	NCT06197126	Cervical Cancer Radiotherapy Prognostic Mode... MRI	Treatment mainl...	20 Years - 85 Years	Fujian Cancer Hospital
A Predictive Model for Early Metastasis in Cervical Cancer Patients After Radiotherapy	NCT06101966	Cervical Cancer Radiotherapy Distant Metasta... Prognostic Mode... Risk Factor	external pelvic...	20 Years - 85 Years	Fujian Cancer Hospital
A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)	NCT03121768	Oncology Bladder Cancer Superficial Bla... Recurrence Progression BCG		18 Years -	Mansoura University
A New Prognostic Score Model for Pancreatic Ductal Adenocarcinoma	NCT05547074	Neoplasms Pancr...	pancreatic canc...	-	Zhejiang University
MRI-based Signatures for Survival Prediction in Cervical Cancer With Radiotherapy	NCT06197126	Cervical Cancer Radiotherapy Prognostic Mode... MRI	Treatment mainl...	20 Years - 85 Years	Fujian Cancer Hospital

Spots Global Cancer Trial Database for prognostic model