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Carcinoma, Renal Cell clinical trials

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NCT ID: NCT03804320 Recruiting - Kidney Cancer Clinical Trials

Protocol Active Surveillance Small Renal Masses (SRMs)

Start date: April 29, 2015
Phase: N/A
Study type: Interventional

Prospective study of active surveillance, non-randomized, multicentric, in asymptomatic patients over the age of 50 years, not affected by other tumors, with occasional diagnosis of single monolateral solid renal mass equal to or less than 2 cm of diameter. Diagnosis will be performed with chest CT abdomen with contrast and / or MRI abdomen with Gadolinium (Gd); during the first year of active surveillance, the patient's status will be evaluated at 3, 6, 9 and 12 months from the diagnosis and, subsequently, according to the schedule of events shown in the table "Event Planning" At the end of the 5 years of follow up, the patient will be entrusted to his / her own treating physician, with indication to perform abdomen and chest x-ray echography every 6 months and thoracic abdomen TAC with contrast and / or MRI abdomen with (Gd) every 2 years up to 10 years from instrumental radiological diagnosis and registration and communication of the possible date of death and cause The primary caregivers and the patient will be contacted annually by the promoter center of the study at the end of the first 5 years of study follow up and the data will be entered in the database by the promoter center. The indication to surgical treatment or ablative treatment will be considered in the following cases: 1. appearance of metastasis 2. increase of the maximum diameter of the renal mass equal to or greater than 4 cm 3. time of doubling of the tumor mass size less than or equal to 12 months 4. appearance of symptoms associated with renal disease (pain, haematuria) 5. appearance of paraneoplastic syndrome (fever, cachexia, hypercalcemia, polycythemia, ranulocytosis) 6. willingness expressed by the patient to undergo surgery or ablative operation In the presence of at least one of the aforementioned criteria, the attending physician can evaluate the possible execution of renal biopsy. The finding of renal biopsy proved negative for neoplasia may allow the continuation of the active surveillance procedure undertaken, independently indi - ding from the presence of one of the above mentioned criteria. If the renal biopsy is negative, the therapeutic decision (continuation of the follow up within the protocol in question, surgery or exit from the protocol) will be agreed between the patient and the patient. In the case of a positive renal biopsy for renal neoplasia, the patient may be a candidate for renal tumorectomy / radical nephrectomy.

NCT ID: NCT03786796 Recruiting - Clinical trials for Renal Cell Carcinoma

Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations

ORCHID
Start date: June 3, 2019
Phase: Phase 2
Study type: Interventional

Single arm, single site, open-label Phase II study of the effects of oral olaparib in participants with metastatic renal cell carcinoma that harbor an inactivating mutation in BAP-1, ATM, BRCA1, BRCA2, PALB2, CHEK2, BRIP1, RAD51C, BARD1, CDK12, CHEK1, FANCL, PP2R2A, RAD51B, RAD51D, or RAD54L who have had prior treatment with at least one immune checkpoint inhibitor or anti-VEGF therapy. Must have measurable disease on CT imaging per RECIST 1.1 criteria.

NCT ID: NCT03749980 Recruiting - Clinical trials for Von Hippel-Lindau Disease

MyVHL: Patient Natural History Study

MyVHL
Start date: January 2012
Phase:
Study type: Observational [Patient Registry]

MyVHL is a multi-patient database which helps researchers identify patterns across VHL patients. MyVHL provides you -and researchers -with more complete information about VHL, like how your lifestyle, medications, and other factors impact the disease and quality of life. These insights help you better understand the condition and help researchers know where to focus their efforts. Due to its rarity, there is less understanding of VHL and the factors that may have an impact. The data individuals provide in MyVHL helps researchers identify and uncover factors that may increase risk, inhibit or slow tumor growth, or lead to an effective cure.

NCT ID: NCT03741426 Recruiting - Renal Cell Cancer Clinical Trials

WIRE - Novel Treatments in Renal Cell Cancer

WIRE
Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

Evaluation of proof of mechanism with relation to ktrans and/or CD8 count when 3 different IMPs are given as monotherapy or as combination therapy. These would be administered in the "window of opportunity", prior to nephrectomy in surgically resectable renal cell cancer

NCT ID: NCT03738488 Recruiting - Clinical trials for Renal Cell Carcinoma

3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement

3DUrologia
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Objectives: Apply 3D- printed biomodels in patients with renal cancer (RCa) and vascular involvement (VTT) to: (1) improve surgical planning, (2) upgrade surgical results, (3) facilitate communication with patients, (4) serve as a model for teaching residents and (5) shortening the learning curve in experienced urologists. Methodology: The design of the study is a randomized clinical trial, to determine the safety, precision, feasibility, predictability, efficacy and efficiency of a surgical strategy based on imaging tests and 3D models regarding the surgical planning in patients with RCa and VTT. This is a longitudinal, prospective, experimental and multicenter study on a cohort diagnosed of RCa and VTT from 2018 in the Virgen del Rocío University Hospital (HUVR) or in the Ramón y Cajal University Hospital (HURC). The study will last for 3 years and will be carried out jointly by the HUVR, the HURC and the IBIS, in a multidisciplinary team made up of urologists, radiologists and engineers.

NCT ID: NCT03736330 Recruiting - Clinical trials for Renal Cancer Metastatic

A Study of Anti-PD-1 Combinations of D-CIK Immunotherapy and Axitinib in Advanced Ranal Carcinoma

Start date: September 8, 2018
Phase: Phase 2
Study type: Interventional

Phase II clinical trial to investigate the safety, clinical activity and toxicity of combinations of D-CIK and low dose anti-PD-1 antibody in patients with metastatic renal cell carcinoma treated with axitinib.

NCT ID: NCT03734614 Recruiting - Clinical trials for Aspirin as Adjuvant Therapy in Patients With Surgically Treated High Risk Renal Cell Carcinoma

Preventive Effects of Aspirin as Adjuvant Therapy in Patients With Locally Advanced Renal Cell Carcinoma

Start date: October 8, 2018
Phase:
Study type: Observational

The study evaluates the protective effect of low-dose aspirin use as adjuvant therapy on locally advanced renal cell carcinoma in users and non-users of aspirin in Renji Hospital, Shanghai, China.

NCT ID: NCT03694912 Recruiting - Clinical trials for Clear Renal Cell Cancer (< 7cm Size)

Development and Evaluation of High Risk Group Prediction Model in T1 Stage Renal Cell Cancer Using Molecular Biomarkers

Start date: November 1, 2018
Phase:
Study type: Observational

For the appropriate individualized treatment of T1-stage renal cell carcinoma with heterogeneous biological features, the expression of PBRM1, SETD2, BAP1, KDM5C and the newly proposed FOXC2 and CLIP4, are compared with clinical features. The investigators evaluated the efficacy of FOXC2 and CLIP4 as prognostic biomarkers and developed a high risk prediction model based on these results. In a previous study, the investigators evaluated the efficacy of FOXC2 and CLIP4 as prognostic biomarkers and reported their association with synchronous metastasis in renal cell carcinomas less than 7 cm in size. The investigators analyzed the expression level of renal cell carcinoma according to the size and malignancy (Fuhrman grade) of renal cell carcinoma in T1-stage clear cell type renal cell carcinoma of tumor size less than 7cm. The aim of this study was to analyze the association of tumor recurrence or metastasis, cancer specific survival rate, overall survival rate, tumor size, malignancy and T stage in postoperative biopsy. For expression analysis, PCR amplification and bidirectional Sanger sequencing and mRNA expression analysis (qRT-PCR) were used. For statistical analysis, Fisher exact test, Wilcoxon exact 2-tailed test, Cox proportional hazard regression analysis and competing risk method were used. In this study, the investigators compared the expression of PBRM1, SETD2, BAP1, and KDM5 with newly proposed biomarkers, FOXC2 and CLIP4 and demonstrate the prognostic value of FOXC2 and CLIP4 as new prognostic biomarkers and compared the clinical outcomes with the clinical outcome. Based on these results, the investigators propose a high risk prediction model for individualized treatment of T1-stage renal cell carcinoma. This study is expected to establish a new prediction model and molecular biologic stage for risk stratification of T1-stage renal cell carcinoma patients and apply genetic test for selection of optimal tailored treatment for T1-stage renal cell carcinoma. In addition, it will be an important basic data of the molecular biologic mechanism of metastasis in early renal cell carcinoma and may be used as a basic data for the development and selection of customized therapeutic agents in patients with distant metastasis.

NCT ID: NCT03685448 Recruiting - Clinical trials for Renal Cell Carcinoma

ANZUP - Non-clear Cell Post Immunotherapy CABozantinib (UNICAB)

UNICAB
Start date: April 11, 2019
Phase: Phase 2
Study type: Interventional

Renal cell carcinoma (RCC) is the 9th most common cancer in Australia, the 10th most common cancer in Western populations.~75% of kidney cancers are clear-cell renal cell carcinomas (ccRCC). Many patients present with advanced or unresectable disease at diagnosis and a number of treatments are now available for metastatic ccRCC included vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs), mTOR inhibitors, and cytokines. More recently first line use of immunotherapy demonstrated improved survival with checkpoint inhibitors. While many patients benefit from first-line treatment, progression is inevitable and these treatments remain on the whole palliative. Second-line VEGFR TKIs, mTOR inhibitors and immunotherapy have some benefit but in a smaller increment than first-line treatment. While ~75% of kidney cancers are the clear-cell variant, ~25% of kidney cancers are non-clear cell histology (nccRCC) and include papillary, chromophobe, sarcomatoid, collecting duct carcinoma, Xp11 translocation carcinoma and unclassified. Patients with non-ccRCC have significantly lower response rates and poorer median progression-free survival and overall survival than those with ccRCC. Non clear cell histologies have largely been excluded from large phase III randomised clinical trials and therefore the optimal treatment and sequencing of therapies for these patients remains unclear. Despite recent unprecedented advances in treatment, there continues to be an unmet need to improve outcomes for patients with previously untreated, unresectable or metastatic renal cell carcinoma. This is particularly relevant in non-clear cell RCC. Because it is a rarer subtype of metastatic renal cell carcinoma, it is more challenging to study, and treatment efficacy data is sparse. The research project is testing a new treatment for participants with locally advanced or metastatic non-clear cell kidney cancer. The new treatment involves a drug called Cabozantinib (also known as Cabometyx). This drug has been used previously in many cancers, including clear cell kidney cancer and thyroid cancer. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of Cabozantinib. Cabozantinib is a anti-cancer drug that works by blocking cancer cell growth. It blocks particular proteins called protein kinases on cancer cells. Protein kinases encourage the cancer to grow. Cabozantinib is called a multi kinase inhibitor because it blocks a number of these proteins. How well cabozantinib works in cancer of the kidney will be tested by measuring the change in size of your tumours that are seen on CT scans. Cabozantinib is approved to treat clear cell kidney cancer and thyroid cancer in Australia. It has not been tested in people with non-clear cell kidney cancer. About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia. Even though this study may be suitable for you, it is possible that you may not be enrolled in this study. This research study has been initiated by Dr. David Pook, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Ipsen is supplying

NCT ID: NCT03682289 Recruiting - Endometrial Cancer Clinical Trials

Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors

Start date: January 17, 2019
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well Ataxia telangiectasia and Rad3-related (ATR) kinase inhibitor AZD6738 works alone or in combination with olaparib or durvalumab in treating participants with renal cell carcinoma (RCC), urothelial carcinoma, all pancreatic cancers, endometrial cancer, and other solid tumors excluding clear cell ovarian cancer that have spread to nearby tissue or lymph nodes or other parts of the body. ATR kinase inhibitor AZD6738 and olaparib or durvalumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not known if giving ATR kinase inhibitor AZD6738 with or without olaparib or durvalumab may work better in treating participants with solid tumors.