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NCT ID: NCT04803188 Enrolling by invitation - Clinical trials for Prostate Cancer (Diagnosis)

Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I

ProSa-I
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

Prostate Cancer (PCa) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA value has cause overdiagnosis of clinically insignificant prostate cancer (ciPCa) for many years, with lack of survival improvement. Non-contrast MRI, on the other hand, has become one of the most promising MRI applications, as it is a more sensitive test able to perform clinically significant PCa early detection. With this background the primary endpoint was to investigate the role of non-contrast MRI (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test, in a randomized fashion.

NCT ID: NCT04802980 Recruiting - Solid Tumor Clinical Trials

A Study of HB002.1T Plus Chemotherapy in Subjects With Solid Tumor

Start date: April 28, 2020
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of HB002.1T in combination with different chemotherapy regimens administered to patients with advanced solid tumors.

NCT ID: NCT04801355 Recruiting - Clinical trials for Colorectal Neoplasms, Benign

Full-thickness Laparo-endoscopic Excision vs Laparoscopic Colectomy for Colonic Tumors

FlexLaC
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Adenoma - carcinoma is a classic pathway of carcinogenesis. On this basis, timely removal of colon adenomas is a prophylactic measure to prevent colon cancer. The standard treatment of colorectal adenomas is endoscopic mucosal resection or submucosal dissection (ESD). In 10 - 15% of cases the ESD is impossible, due to the size of the tumor, inconvenient localisation in the area of the diverticulum or appendix, the presence of fibrosis in the submucosal layer (Currie AC framework IDEAL // Colorectal Disease. 2019. No. 9 (21). P. 1004-1016.), (Suzuki S. Short-term results of laparoscopic endoscopic cooperative surgery of colorectal tumors (LECS-CR) in cases of endoscopically inoperable colorectal tumors // Surgery today . 2019. No. 12 (49). S. 1051-1057.). In that cases the segmental colectomy is justified. An alternative to colectomy is a hybrid laparo-endoscopic surgery, which reduce postoperative hospital stay, incidence of complications and provide a comparable level of radicality (Lee SW, Garrett KA, Milsom JW Combined endoscopic and laparoscopic surgery (CELS) // Seminars on surgery of the colon and rectum. 2017. No. 1 (28). S. 24-29). Thus, the planned study will contribute to the introduction into practice of an alternative method of management with tumors of the colon without signs of invasive growth when the endoscopically removal is impossible.

NCT ID: NCT04801342 Recruiting - Clinical trials for Metastatic Malignant Neoplasm to Brain

Neurocognitive Outcome of Bilateral or Unilateral Hippocampal Avoidance WBRT With Memantine for Brain Metastases

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Brain metastases are the most common brain tumors in adults. It is estimated that around 10-30% of cancer patients would develop brain metastases during the course of their illness. Whole brain radiotherapy (WBRT) is the treatment of choice for the majority of patients with brain metastases. WBRT yields high radiologic response rate (27~56%) and is effective in rapid palliation of neurologic symptoms as well as prolongs time to neurocognitive function decline caused by intracranial lesions. By using conventional fractionation, more than one- third of patients developed late neurocognitive toxicity while memory impairment was the most common symptom. The incidence is even higher when a formal and sensitive neurocognitive assessment was prospectively evaluated. With more long-term survivors nowadays, it has become increasingly important to minimize neurocognitive function decline and maintain quality of life in patients with brain metastasis. The function of hippocampus is cooperation in learning, consolidation and retrieval of information and essential for formation of new memories. Bilateral and unilateral radiation injury of the hippocampus is known to alter learning and memory formation. Several preclinical studies support the hypothesis of hippocampus-mediated cognitive dysfunction by ionizing radiation. Clinical studies show increase in radiation dose to hippocampus is associated with subsequent neurocognitive function impairment in adult and pediatric patients. Furthermore, the result of phase III randomized trials suggested hippocampal avoidance plus Memantine significantly reduce the risk of neurocognitive impairment at 6 months from 68.2% in control arm with standard WBRT to 59.5% in experimental arm. In the investigator's prior investigation, patients received conformal WBRT with bilateral hippocampal avoidance also had significant less declines in verbal memory at 6 months. Previous studies showed the right and left hippocampus exert different neurocognitive functions. Several retrospective studies also demonstrated that the radiation dose to the left hippocampus is more related to neurocognitive impairment. Planning study and investigation showed that by avoiding the left hippocampus alone, the radiation dose to the spared unilateral hippocampus is further decreased. In present study, a single blind randomized phase II trial is designed to investigate the effectiveness of neurocognitive function preservation using conformal WBRT with bilateral or unilateral hippocampal avoidance and memantine.

NCT ID: NCT04801095 Recruiting - Colorectal Cancer Clinical Trials

A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors

Start date: July 14, 2021
Phase: Phase 1
Study type: Interventional

This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of WM-S1-030 in patients with advanced solid tumors.

NCT ID: NCT04801082 Not yet recruiting - Pain Management Clinical Trials

Endoscopic Ultrasound Guided Coeliac Plexus Neurolysis for Cancer Pain

Start date: March 2021
Phase: Phase 4
Study type: Interventional

Many cancer patients suffer from intractable pain and which is often suboptimally controlled by even strong opioid analgesics. Coeliac plexus neurolysis (CPN) is procedure which intended to permanently destroy the nociceptive pathway that transmits the pain caused by the tumour. It can be with different approaches, such as percutaneously guided by fluoroscopy, echo-endoscopically or surgically with endoscopic approach being the more popular one in many centers equipped with echo-endoscopic services. The effect of CPN has been well established by some retrospective series. The overall response rate to CPN ranges from 70-90%, however, the analgesic effect is limited and up to roughly around 3 months. It is believed that the short-lasting analgesic effect is related to incomplete neurolysis by absolute alcohol injection. Recently, radiofrequency ablation (RFA) of coeliac plexus has been introduced as another mode of CPN. So far, only one small single center randomized controlled trial (RCT) suggesting superior performance in favour to CPN using RFA. This result has to be validated and by a RCT with larger sample size. In addition, data concerning the quality of life (QOL) improvement and cost-effectiveness need to be further elucidated. Therefore, the aim of this study is to perform a RCT to look into these issues.

NCT ID: NCT04800822 Active, not recruiting - Solid Tumor Clinical Trials

PF-07284892 in Participants With Advanced Solid Tumors

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.

NCT ID: NCT04800627 Terminated - Clinical trials for Metastatic Malignant Solid Neoplasm

Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor

Start date: March 29, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial identifies the side effects and best dose of pevonedistat when given together with pembrolizumab in treating mismatch repair deficiency (dMMR)/high-frequency microsatellite instability (MSI-H) solid tumor that has spread to other places in the body (metastatic) or has spread to nearby tissue or lymph nodes (locally advanced) and cannot removed by surgery (unresectable). Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pevonedistat and pembrolizumab may kill more tumor cells.

NCT ID: NCT04799431 Withdrawn - Clinical trials for Colorectal Cancer Metastatic

Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer

Start date: May 3, 2023
Phase: Phase 1
Study type: Interventional

Phase 1 study evaluating feasibility, safety, and immune response to a personalized neoantigen vaccine combined with retifanlimab for MMR-p mCRC and mPDAC patients with measurable disease following first-line FOLFIRINOX/FOLFOXIRI (FFX).

NCT ID: NCT04799080 Completed - Breast Cancer Clinical Trials

Chemotherapy-induced Peripheral Neuropathy (CIPN) on Motor and Sensory Function

Start date: March 6, 2021
Phase:
Study type: Observational

As cancer survival rates have been increased due to technological developments and early detection strategies, there has been been a growing need to assess the effect of long-term complications and adverse effects upon patients' functionality and quality of life. Chemotherapy, which is accepted to be the body of systemic adjuvant therapy is attributed to long-term survival, yet some side effects such as sarcopenia, loss of muscle strength and functional capacity, fatigue, and sensory disturbances due to the neurotoxic effects have been well known. Chemotherapy-induced peripheral neuropathy (CIPN) is a condition that is characterized by main loss of cutaneous sensation especially in the distal part of the extremities. CIPN affects approximately 30-40% of patients with cancer undergoing chemotherapy. Loss of sensation in distal sides of upper and lower extremities may cause not only deterioration of fine hand skills but also loss of balance and thereby one's mobility and independence are detrimentally affected. Thus, this study is aimed to assess CIPN in patients with cancer undergoing chemotherapy in a longitudinal design by assessing the cutaneous function of the sensory nerves and related effect of motor function.