Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Each subject receive BCMA CAR T-cells by intravenous infusion

BCMA CAR-T cells

He Huang, MD

Mingming Zhang, MD

Clinical Trial for the Safety and Efficacy of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

This is a single arm, open-label, single-center study. This study is indicated for newly diagnosed multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 40 patients will be enrolled. Primary objective is to explore the safety and efficacy

A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Assessment of ORR (ORR = sCR+CR+VGPR+PR+MR) at Month 6, 12, 18 and 24

Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)

Proportion of subjects who achieved a partial response (PR)

Death from any cause from the beginning of cell transfusion

Yake Biotechnology Ltd.

Zhejiang University

Clinical Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hyman Muss, MD

The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.

Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer

To measure and correlate baseline p16INK4a expression in subjects with stage I-IV breast cancer starting a new course of chemotherapy with a post cycle 1 chemotherapy absolute neutrophil count (ANC).

To explore the associations between p16INK4a expression at baseline and amount of vigorous physical activity, smoking habits, and weekly alcohol consumption.

To explore the associations between p16INK4a expression at baseline and other chemotherapy-related toxicities, including the maximum toxicity experienced during that course of chemotherapy.

To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.

UNC Lineberger Comprehensive Cancer Center

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

The delivered intervention will be to provide patients with an interdisciplinary team-based approach defined as care provided by a variety of professionals, each having their own domain of expertise, defined roles and responsibilities, who work together and meet to discuss patient needs and develop comprehensive treatment plans. Team composition will include physicians, a dedicated nurse, and allied professionals (e.g., dieticians, social workers, psychologists). The dedicated nurse will have a central integrative role in this interdisciplinary team and will provide patients with information about their illness and treatment, symptom management, emotional support, and reference to other resources when needed

Patients in the control group will be provided with usual care, comprised of meetings with surgeons and endocrinologists. All patients in this study will be provided with an information website containing information on their cancer, treatments, and treatment side-effects.

Three meetings will be scheduled with the oncology dedicated-nurse. First meeting: information about the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; as well as surgery and its' short- and long-term consequences. Second meeting: information on radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations. Third meeting: how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities. The dedicated nurse, in collaboration with the Department of Nursing and ENT, will develop and implement an interdisciplinary team-based approached developed for this study according to guidelines of the Programme québécois de lutte contre le cancer (PQLC).

Interdisciplinary Team-Based Approach

Usual Care Control

Melissa Henry, PhD

While thyroid cancer is generally associated with a favourable prognosis, there is a discrepancy with how important if not traumatic its impact can be on patients. Quality of life (QoL) decreases in the year following a thyroid cancer diagnosis, constituting an optimal period for a preventive intervention. The goal of this study is to evaluate the impact of offering an interdisciplinary team-based care approach for newly diagnosed thyroid cancer patients, including a dedicated nurse who will provide important psychoeducational elements identified in previous focus group studies of thyroid cancer patients, i.e., information on: the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; surgery and its' short- and long-term consequences; radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations; and how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities.

The investigators will conduct a 2-arm Randomized Controlled Trial comparing an Interdisciplinary Team-Based Care Approach to usual care.

The primary research question will be: Does adding the Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) to usual care (EG) increase levels of overall QoL among newly diagnosed thyroid cancer patients, compared with those receiving usual care (UC), at 9 months post-randomization (i.e., after all of the dedicated-nurse meetings are administered) as judged by scores on the Functional Assessment of Chronic Illness Therapy-General (FACT-G)? Primary hypothesis: The EG will report higher scores of overall QoL on the FACT-G than the UC at 9 months post-randomization.

Secondary research questions: The investigators plan to evaluate ITCA-ThyCa effects on secondary outcomes such as level of: physical health (SF-36 Physical Health subscale), mental health (SF-36 Mental Health subscale), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; FACIT-F), anxiety and depression (Hospital Anxiety and Depression Scale; HADS), and negative illness perception (Illness Perception Questionnaire - Revised (IPQ-R). The investigators also plan to explore ITCA-ThyCa effects on satisfaction with care (16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care) and healthcare service use (types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation). Hypotheses: The EG will report a higher level of physical and mental health on the SF-Physical and Mental Health subscales, respectively; and a lower level of fatigue on the FACIT-F, anxiety and depression on the HADS, and negative illness perception on the IPQ-R; compared with the UC at 9 months post-randomization.

All of the abovementioned changes will be present throughout the treatment, namely at 7-10 days and 5 months post-randomization (i.e., immediately after each of the meetings planned with the dedicated nurse).

All of the abovementioned changes will persist at 12 months post-randomization (i.e., corresponding to 6 months after all anti-cancer treatments are completed and 3 months after all dedicated-nurse meetings have been administered).

Feasibility and acceptability (9 first months of the trial):

The investigators plan on testing the feasibility and acceptability of the 2-arm RCT of ITCA-ThyCa during the first 9 months of the trial (once the investigators start recruiting, after the first 3-6 months dedicated to hiring our personnel and developing the manual of our approach). During this phase, the investigators will aim to address the following research questions:

1. Can the investigators recruit a sufficient number of patients (i.e., a minimum of 60 patients over 6 months or 10/month) and retain a sufficient proportion of thyroid cancer patients (i.e., at least 80% at 7-10 days, 5 months or 9 months post-randomization) in both trial arms?
2. Is ITCA-ThyCa acceptable to at least 80% of EG thyroid cancer patients? Secondary pilot study questions
3. Which evaluation time should be primary post-randomization, based on an acceptable retention rate of 80%?
4. What variance estimates can be used to inform calculation of sample size for the full study?

If the design remains the same following this pilot, the investigators aim to roll in the pilot data in the full trial.

Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients

Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) For Newly Diagnosed Thyroid Cancer Patients: Randomized Controlled Trial

Measure: Functional Assessment of Chronic Illness Therapy-General (FACT-G)

Measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

Measure: Hospital Anxiety and Depression Scale (HADS)

Illness Perception Questionnaire - Revised (IPQ-R)

16 questions of the NRC Picker satisfaction survey measuring patient satisfaction with care

Types of professionals consulted, frequency of visits, and time elapsed between referral and first consultation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of BCMA CAR-T Cell Therapy for Newly Diagnosed Multiple Myeloma	NCT05712083	Multiple Myelom... New Diagnosis T...	BCMA CAR-T cell...	-	Zhejiang University
Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients	NCT01305954	Breast Cancer		18 Years -	UNC Lineberger Comprehensive Cancer Center
Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients	NCT01994200	Thyroid Cancer	Interdisciplina... Usual Care Cont...	18 Years -	Jewish General Hospital

Spots Global Cancer Trial Database for new diagnosis