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Neoplasms clinical trials

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NCT ID: NCT05661292 Recruiting - Clinical trials for Colorectal Cancer Screening

Validation of Advanced Colorectal Neoplasm Risk Categories in a Prospective Cohort in Mexico

COLOFIT
Start date: August 1, 2019
Phase:
Study type: Observational

Worldwide, there are 1,361,000 new cases of colorectal cancers (CRC) annually, with 694,000 deaths. However, the incidence varies by up to a factor of 10x between high and low incidence countries (eg. USA vs Mexico, incidence rate of 42.54 vs 7.44 / 100,000 inhabitants). Mexico is considered a low-incidence country, with 8,651 new cases and 4,694 deaths annually. CRC is a preventable and detectable disease. Screening programs established in high-incidence countries have managed to reduce the incidence and mortality from this disease and it is considered a cost-effective strategy. In less developed countries where there are no screening programs for CRC, the highest number of deaths occurs despite having the lowest number of cases. It is recognized that a barrier to establishing a screening program in a country with low incidence and limited resources is cost-effectiveness. The prevalence of Advanced Colorectal Neoplasia (ACN) detected by screening colonoscopy in a Mexican cohort of 1172 INNSZ patients was 2.9%. In the US the prevalence is 7.6%. The number of colonoscopies to be performed to detect ACN was estimated at 34 for Mexico and 13 for the US, which suggests that the cost-effectiveness of screening colonoscopy could be 3 times lower in our country. In Mexico there is no national screening program for CRC. The eligible population (adults between 50 and 75 years old) for CRC screening is estimated in 20 million of Mexicans. It is recognized that Mexico does not have enough financial resources nor the infrastructure to screen the entire eligible population either by direct colonoscopy, or by FIT (fecal immunochemical test) followed by colonoscopy. With a 5% frequency of positive FIT, nearly 1,000,000 follow-up colonoscopies would be required annually in a population screening program. An alternative could be to offer screening based on risk, which means only offering screening to the highest-risk population. There are calculators to predict the risk of identifying ACN in a screening colonoscopy, however, none have been developed and validated in the Mexican population. The weight of the risk factors associated with ACN in the Mexican population could be different, so it is necessary to develop and validate an ACN risk calculator that allows the Mexican population to be stratified and to concentrate screening efforts on the population at highest risk.

NCT ID: NCT05661201 Recruiting - Solid Tumor Clinical Trials

NEROFE and Doxorubicin in KRAS-mutated ST2-positive Solid Tumors

Start date: April 12, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about the safety of NEROFE and doxorubicin and how well it works in patients with advanced/unresectable or metastatic solid KRAS-mutated and ST-positive solid tumors. The main question it aims to answer is to find the recommended dose and scheduled for the combination of NEROFE and doxorubicin. Participants will receive weekly doses of NEROFE and doxorubicin.

NCT ID: NCT05660421 Recruiting - Clinical trials for Malignant Solid Neoplasm

Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors

Start date: September 30, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial tests how well itacitinib works in in patients with immune related adverse events (irAEs) arising from immune checkpoint inhibitors (ICI) that do not respond to steroids (steroid refractory). Steroids are the usual treatment for these side effects. However, sometimes steroids do not improve or fix the side effects. Giving itacitinib may be effective in treating patients with known or suspected problems coming from ICIs, that do not resolve or improve with steroids, by reducing the patients immune system response that can cause the irAEs.

NCT ID: NCT05656248 Recruiting - Myeloid Neoplasm Clinical Trials

Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms

Start date: January 17, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn the effects of treatment with an investigational drug, CPX-351 in patients with secondary myeloid neoplasms (SMNs).

NCT ID: NCT05653934 Recruiting - Pain, Postoperative Clinical Trials

Use of VIrtual REAlity to Reduce Postoperative Anxiety and Pain After Surgery for Colorectal Cancer

VIREA
Start date: May 2023
Phase: N/A
Study type: Interventional

In patients operated for colorectal cancer, pain, anxiety and depression are important factors in postoperative rehabilitation. The use of new technologies, as virtual reality immersion, could further improve their postoperative management. To date, no study has evaluated the potential benefits of using virtual reality before and after colorectal cancer surgery. The main objective is to determine if virtual reality can reduce postoperative anxiety in patients undergoing colorectal cancer surgery. To answer this question, the investigators plan to execute a randomized controlled, single-center, open-label, superiority interventional trial. Patients will be randomized into 2 parallel arms: 1 interventional "virtual immersion" arm and 1 "control" arm. Patients with colorectal cancer, regardless of oncological stage, or a colorectal lesion deemed endoscopically unresectable, with an indication for elective surgical management by laparotomy or laparoscopy will be included. For patients in the interventional arm, virtual reality headset is put on the day before the operation and in the morning just before going down to the operating theatre. Colorectal cancer surgery then proceeds as usual. In the postoperative period, virtual reality sessions are offered every day and on request without any limit in number. Virtual reality immersion offers a visual and auditory experience during a soothing journey through visual worlds filmed in natural environments. This is a purely contemplative mode, lasting maximum 30 minutes. For the control arm, patients are treated according to the usual practices of the department and do not have access to virtual reality. The main purpose is to show a greater decrease in anxiety in the interventional group by measuring the absolute difference between the State-Trait Anxiety Inventory scores before surgery and at discharge.

NCT ID: NCT05653869 Recruiting - Clinical trials for RET-altered Solid Tumors

A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions

Start date: February 6, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of APS03118 administered orally in participants with RET-altered solid tumors.

NCT ID: NCT05653661 Recruiting - Clinical trials for Advanced Malignant Solid Neoplasm

Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors

Start date: January 12, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of a new drug called nab-paclitaxel/STI-3031 complex (AP160-complex) in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have spread from where they first started (primary site) to other distant parts of the body (metastatic). AP160-complex is a combination of the chemotherapy drug nab-paclitaxel, and the immunotherapy drug STI-3031. Nab-paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. AP160-complex may work better than standard therapies in treating advanced or metastatic solid tumors.

NCT ID: NCT05651022 Recruiting - Solid Tumor, Adult Clinical Trials

DECOY20 Study in Patients With Advanced Solid Tumors

Start date: February 28, 2023
Phase: Phase 1
Study type: Interventional

INDP-D101 is a Phase 1, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 in patients with locally advanced or metastatic solid tumors.

NCT ID: NCT05650242 Recruiting - Solid Tumors Clinical Trials

A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid Tumors

Start date: January 31, 2023
Phase: Phase 1
Study type: Interventional

This is an open label Phase 1, First in Human trial designed to evaluate the safety, tolerability pharmacokinetics, preliminary efficacy of BA1106 in participants with advanced solid tumors.

NCT ID: NCT05649345 Recruiting - Clinical trials for Advanced Solid Tumor

TR64 in Patients With Advanced Solid Tumors

Start date: January 12, 2023
Phase: Phase 1
Study type: Interventional

This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.