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Neoplasms clinical trials

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NCT ID: NCT03498183 Recruiting - Clinical trials for Malignancy of Thyroid Nodules

Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (≥15 mm) Classified Bethesda III or IV on Cytology

MIBI-THYR
Start date: January 17, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The main objective of the study is to show that the addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.

NCT ID: NCT03497429 Completed - Clinical trials for Advanced Solid Tumors

A Study of Niraparib as Single Agent in Participants With Advanced Solid Tumors

Start date: April 5, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Niraparib in Japanese participants with advanced solid tumors.

NCT ID: NCT03495921 Terminated - Neoplasms Clinical Trials

A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide

VITA
Start date: August 21, 2018
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial was to compare participants with first relapse or refractory Ewing's sarcoma when treated with investigational product (Vigil) in addition to the standard treatment of irinotecan and temozolomide compared to the standard treatment of irinotecan and temozolomide alone. The main question it aimed to answer is "Will participants who receive Vigil in addition to irinotecan and temozolomide have a prolonged time to progression and improved quality of life compared to the participants who receive irinotecan and temozolomide alone?".

NCT ID: NCT03493672 Completed - Neoplasms Clinical Trials

Counting Steps! Integration of Objectively Assessed Physical Activity and Fitness With Smartphones in Clinical Oncology Practice.

Start date: October 18, 2017
Phase:
Study type: Observational

Rationale: Optimal selection of patients with cancer eligible for a clinical trial, is of utmost importance, but can be very difficult. Patients must be sufficiently fit and have a reasonable life expectancy, to be eligible for participation in clinical trials. In current clinical practice, the ECOG/WHO performance status, is used to select patients for clinical trials, and it has proven to be an independent predictor of survival in patients with cancer. This score is based on a subjective assessment of the treating physician, which can, together with the strong motivation of some patients to participate, lead to overestimation of a patient's actual physical condition and may thereby contribute to early trial discontinuation. Participation of these patients may not only harm them, but will also hamper trial conduct and outcomes. Both, physical activity and fitness are positively associated with survival in patients with cancer. This gives rise to the investigators hypothesis that objective measurements can be of added value in the selection process. Additionally, preliminary results in 50 patients with cancer that participated in part 1 of the "Counting Steps!" project revealed that the smartphone can produce valid and reliable assessments of physical activity and fitness, and the user friendliness was rated "good" by patients. The investigators hypothesize that measurements of physical activity and fitness with smartphones will provide more objective and accurate information about the actual physical condition of a patient with cancer. With a better prediction of trial feasibility (without early trial discontinuation) and overall survival in patients participating in phase I-II clinical trials, the selection of eligible trial participants could be improved. In this way, it is possible to more adequately identify patients who are most likely to successfully participate in a clinical trial and thereby have the highest chance to benefit from trial participation. Successful trial participation will provide optimal palliative care to patients and improve their quality of life. In addition, it may prohibit participation of patients who are currently incorrectly included in clinical trials and suffer from toxic therapies without having a chance to benefit from treatment. A better selection of patients will be beneficial for the trial outcomes and subsequently for the development of new anticancer drugs or treatment regimens. Objective: The investigators aim to: 1. Identify whether objective smartphone measurements of physical activity and fitness is predictive for trial feasibility (without early trial discontinuation) in patients with cancer participating in phase I-II clinical trials. 2. Evaluate the feasibility and acceptability of the use of the smartphone's objective assessments of physical activity and fitness in clinical practice. Study design: Observational study Study population: • 135 patients with hematologic or solid cancer referred to the VU medical center for participation in phase I-II clinical trials. Intervention: In this observational study, patients will not receive an additional intervention. Main study parameters/endpoints: Prior to the start of medical treatment, physicians will rate the performance status, and participants will wear a smartphone for one week to measure the daily number of steps, to complete the 6 minute walk test using the smartphone application, and to fill out the 5-item physical function subscale of the EORTC QLQ-C30. These assessments will be repeated after 4 and 8 weeks. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No extra visits to the hospital will be necessary. Participation in this study will not cause any additional risks or expected benefits for participants. It will only deliver knowledge, which may be used in the future to better select patients eligible for participation in phase I-II clinical trials or even for regular treatment. Participation in the study will only cost time for patients. The patients will be asked to wear a smartphone for a week, have to perform a six-minute walk test (6MWT) once in this week and have to complete a questionnaire about their own physical function once. Subsequently, patients will repeat those measurements 4 and 8 weeks after inclusion in the phase I-II clinical trial.

NCT ID: NCT03493451 Completed - Clinical trials for Anaplastic Large Cell Lymphoma

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Start date: April 13, 2018
Phase: Phase 2
Study type: Interventional

This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts: - Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) - Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) - Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).

NCT ID: NCT03491631 Active, not recruiting - Tumor, Solid Clinical Trials

Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors

Start date: November 20, 2018
Phase: Phase 1
Study type: Interventional

This phase I trial is designed to efficiently identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) for the combination therapy regimen of the IDO1 inhibitor SHR9146 when administered in combination with immune checkpoint PD-1 inhibitor SHR-1210 plus VEGFR inhibitor Apatinib or not in subjects with advanced/metastatic solid tumors. All subjects will receive the same standard SHR-1210 plus Apatinib (only three drugs group)regimen, while SHR9146 in doses increasing from 100 mg twice daily to, potentially, 600 mg twice daily. Once the recommended regimen has been identified, subjects with the selected tumor type will be enrolled into expansion cohorts based upon prior safety and tolerability data.

NCT ID: NCT03491345 Active, not recruiting - Clinical trials for MSI-H Mutation Tumor

K-Basket, Avelumab, Biomarker-driven, Advanced Solid Tumor

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

Investigators have conducted K-BASKET trial (Korea-Biomarker-driven multi-arm drug-screening, knowledge and evidence-generating targeted trial), which was based on the specific genetic aberration, not the cancer type, which could accelerate matching the right drug to the right target so that every cancer patient could get the right specific drug based on the specific genetic biomarker, like NCI-MATCH trial. Next generation sequencing (NGS) focusing panel has the mutation and copy number variation of MET, PIK3CA and AKT. Investigators will open new treatment arms during the progress of K-BASKET trial. Patient with PD-L1 positive or EBV positive or MSI-H or POLE/POLD1 mutation tumor will be assigned to Avelumab monotherapy.

NCT ID: NCT03490838 Terminated - Prostatic Neoplasm Clinical Trials

177Lu-PSMA-R2 in Patients With PSMA Positive Progressive, Metastatic, Castration Resistant Prostate Cancer

PROter
Start date: May 24, 2018
Phase: Phase 1
Study type: Interventional

This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, and the Phase 2 portion will expand into approximately 60 patients documenting the preliminary activity (anti-tumor response) of repeated treatments administered, continuing safety assessments and collecting QoL data.

NCT ID: NCT03488446 Recruiting - Stomach Neoplasms Clinical Trials

Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer(RPLNM)(GIPMCS-1701)

Start date: August 30, 2017
Phase:
Study type: Observational

This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.

NCT ID: NCT03485547 Active, not recruiting - Clinical trials for Blastic Plasmacytoid Dendritic Cell Neoplasm

Study of Venetoclax, a BCL2 Antagonist, for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Start date: August 23, 2018
Phase: Phase 1
Study type: Interventional

This research study is studying a drug as a possible treatment for BPDCN. The intervention involved in this study is: Venetoclax