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Neoplasms clinical trials

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NCT ID: NCT04551521 Recruiting - Clinical trials for Metastatic or Locally Advanced Malignancies

CRAFT: The NCT-PMO-1602 Phase II Trial

Start date: October 13, 2021
Phase: Phase 2
Study type: Interventional

Whole-genome and transcriptome sequencing of patients with advanced solid tumors enrolled in the NCT/DKTK MASTER (Molecularly Aided Stratification for Tumor Eradication Research) program revealed genetic alterations in a substantial proportion of patients including (i) alterations that lead to aberrant activation of BRAF, ERBB2, ALK, and the PI3K-AKT and MAPK pathways and (ii) changes that predict sensitivity to immune checkpoint inhibition, such as high tumor mutational burden and specific alterations of the PD-L1 locus. Within this seven-arm basket phase II clinical trial, we aim to investigate the efficacy of targeted-therapy plus immune checkpoint inhibition in patients with advanced tumors exhibiting one of the following genetic alterations detected within the NCT/DKTK MASTER study: (i) BRAF V600E/K, (ii) ERBB2 amplification and/or overexpression or activating ERBB2 mutation, (iii) ALK rearrangement or activating ALK mutation, (iv) activating mutations or amplification of AKT, loss of PTEN, (v) activating PIK3CA mutations, (vi) abberations predicting increased RAF-MEK-ERK pathway activity; (vii) patients with high tumor mutational burden and/or specific alteration predicting sensitivity to PD-1/PD-L1 inhibition are eligible within this study for immune checkpoint inhibition. Recruitment of adequate patient numbers into these well-defined molecular subgroups is achieved in a multicenter approach including NCT Heidelberg and NCT Dresden as well as DKTK partner sites. Eligible patients will be identified by in-depth molecular characterization of tumors within the NCT/DKTK MASTER program. All study arms are based on similar biometrical assumptions, and sample size as well as power calculations are based on Simon's optimal two-stage design for each study arm separately. The overall aim is to reduce the cumulative hazard of progression-free survival observed within the study (PFS2) compared to the cumulative hazard of the progression-free time before inclusion into the study (PFS1) using a paired log-rank test. The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and 175 patients.

NCT ID: NCT04551378 Recruiting - Clinical trials for Malignant Solid Neoplasm

The Effect of COVID-19 Pandemic on Adolescent and Young Adult Cancer Patients and Survivors

Start date: July 13, 2020
Phase:
Study type: Observational

The study investigates how the COVID-19 pandemic has impacted the psychological, financial, physical, and social well-being of adolescent and young adult (AYA) cancer patients and survivors. AYA cancer survivors have inferior long-term survival compared to the general population, and the negative impact of the global COVID-19 pandemic may be even higher in this vulnerable group. The information gained from this study may provide an opportunity to determine the self-reported COVID-19 specific psychological distress in AYA cancer survivors, and may lead to the development of a targeted intervention to improve physical and psychosocial health for AYA cancer patients and survivors.

NCT ID: NCT04550494 Recruiting - Clinical trials for Metastatic Malignant Solid Neoplasm

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Start date: April 26, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies if talazoparib works in patients with cancer that has spread to other places in the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.

NCT ID: NCT04549246 Recruiting - Clinical trials for Radiation Therapy Complication

Grid Therapy for Tumors of the Head, Neck, Thorax, Abdomen, Pelvis and Extremities.

Start date: June 18, 2020
Phase:
Study type: Observational

This study is an observational registry study evaluating the clinical outcomes of grid therapy. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained, baseline adverse event and QOL data will be collected and subjects will undergo grid therapy and follow-up at 2-4 weeks (for toxicity), and 3-6 months (for toxicities and radiographic control) then per clinical discretion up to 1 year. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 60 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure. See below for the clinical visit flowchart for data collected at baseline and standard clinic visits.

NCT ID: NCT04547634 Recruiting - Cancer Clinical Trials

Telerehabilitation in Oncology Patients

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors

NCT ID: NCT04546945 Recruiting - Clinical trials for Hematologic Malignancies

Aberrant Expression of CD56 in Patients With Hematologic Malignancies.

Start date: July 20, 2020
Phase:
Study type: Observational [Patient Registry]

CD56(cluster of differentiation 56) was found to be ectopically expressed in multiple myeloma . A met analysis indicated that CD56 over expression may be an adverse prognostic factor in AML. To the best of our knowledge, no available data the expression pattern of CD56 in other Hematologic malignancies. This work is designed to evaluate the expression pattern of CD56 in hematologic malignancies.

NCT ID: NCT04541082 Recruiting - Glioblastoma Clinical Trials

Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms

Start date: October 26, 2020
Phase: Phase 1
Study type: Interventional

The primary objective of this Phase 1, open-label, dose-escalation, and exploratory study is to evaluate the safety and tolerability profile (establish the maximum-tolerated dose) and evaluate the occurrence of dose-limiting toxicities (DLTs) following single weekly or multiple-day weekly dose regimens of single-agent, oral ONC206 in patients with recurrent, primary central nervous system (CNS) neoplasms.

NCT ID: NCT04540588 Recruiting - Skin Cancer Clinical Trials

Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

Start date: December 22, 2020
Phase: N/A
Study type: Interventional

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

NCT ID: NCT04539678 Recruiting - Clinical trials for Impact of Treatment With Cytoreducing Agent

SYTHROM Cohort, Myeloproliferative Neoplasia With Normal CBC and Thrombotic Complications

SYTHROM
Start date: May 21, 2019
Phase:
Study type: Observational

Among the etiologies of thrombosis, myeloproliferative neoplasia (MPN) is quite rare but should be investigated in case of thrombosis of atypical localization (digestive or cerebral) or in the context of recurrent idiopathic thrombosis in a young subject. Thrombosis could reveal an underlying MPN through the identification of a JAK2 V617F mutation. Rarely, MPN with thrombotic complications present with normal complete blood count(CBC). In case of a MPN with a thrombotic event but without CBC abnormality, anti-thrombotic treatment is recommended. But there is no recommendation for the indication of cytoreductive therapy and the clinician's decision is often empirical. One of the major complications of for essential thrombocythemia (ET) or polycythemia vera (PV) is thrombosis and an age over 60 is a major risk factor. The treatment of thrombosis associated with TE or PV is based on recommendations the main therapeutic objective of which is to reduce the thrombotic risk. The combination of a cytoreducing agent and antithrombotic treatment is thus proposed in high-risk patients. The efficacy of this management is monitored by assessing CBC with the objective of normalization at <400 G/L of platelets for ET patients and <45% hematocrit in case of PV. The absence of abnormal CBC makes it difficult to justify cytoreduction. The benefit of such a therapy in this context has not been clinically demonstrated. If a cytoreductive therapy is initiated, no biological parameters are available to assess the response to treatment. The objective of this observational study is to evaluate the incidence of recurrence of thrombosis in patients whose thrombotic event revealed an underlying MPN with normal CBC. A comparison of groups treated or not with cytoreductive agents will be performed. Longitudinal monitoring of the patients will provide a better understanding of the nature and kinetics of hematological changes in these patients.

NCT ID: NCT04537936 Recruiting - Solid Tumor Clinical Trials

Psychotherapy Intervention for Latinos With Adv Cancer

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos. Cancer affects patients and their loved ones. Latinos often experience greater challenges due to the cancer. However, few studies and interventions focus on Latinos. We are interested in understanding what affects Latino patients' quality of life, and how to improve it