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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Hematologic

This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.
Hematologic
N/A
Kassim, Adetola
NCT01351545
VICCCTT1158

CIBMTR Research Database

Hematologic

The primary purpose of the Research Database is to have a comprehensive source of
observational data that can be used to study HSC transplantation and cellular therapies.

A secondary purpose of the Research Database is to have a comprehensive source of data to
study marrow toxic injuries.

Objectives:

To learn more about what makes stem cell transplants and cellular therapies work well such
as:

- Determine how well recipients recover from their transplants or cellular therapy;

- Determine how recovery after a transplant or cellular therapy can be improved;

- Determine how a donor's or recipient's genetics impact recipient recovery after a
transplant or cellular therapy;

- Determine how access to transplant or cellular therapy for different groups of patients
can be improved;

- Determine how well donors recover from the collection procedures.
Hematologic
N/A
Kassim, Adetola
NCT01166009
VICCCTT1110

Vincristine Pharmacokinetics in Infants

Pediatrics

This pilot trial compares drug exposure levels using a new method for dosing vincristine in infants and young children compared to the standard dosing method based on body surface area (BSA) in older children. Vincristine is an anticancer drug used to a variety of childhood cancers. The doses anticancer drugs in children must be adjusted based on the size of the child because children vary significantly in size (height, weight, and BSA) and ability to metabolize drugs from infancy to adolescence. The dose of most anticancer drugs is adjusted to BSA, which is calculated from a patients weight and height. However, infants and young children have more severe side effects if the BSA is used to calculate their dose, so new dosing models have to be made to safely give anticancer drugs to the youngest patients. This new method uses a BSA-banded approach to determine the dose. Collecting blood samples before and after a dose of the drug will help researchers determine whether this new vincristine dosing method results in equivalent drug levels in the blood over time in infants and young children compared to older children.
Pediatrics
N/A
Borinstein, Scott
NCT05359237
COGPEPN22P1

Educational Telehealth Program for the Delivery of Care to Cancer Patients in Rural Communities, ENCORE Study

Miscellaneous

This clinical trial evaluates the clinical effectiveness of a multi-level telehealth-based intervention for cancer patients in rural communities. Rural residents face limited accessibility to cancer treatment and supportive care services, transportation barriers, and financial issues. Cancer Thriving and Surviving is an evidence-based self-management intervention with demonstrated efficacy across numerous chronic health conditions with dissemination across the US, inclusive of rural communities. This trial evaluates whether the evidence-based Cancer Thriving and Surviving intervention delivered through telehealth among rural patients may improve patient outcomes.
Miscellaneous
N/A
Friedman, Debra
NCT04758338
VICCPED2013

Enhanced Recovery After Surgery for Pain Management in Patients with Extremity Soft Tissue Sarcoma

Sarcoma

This clinical trial studies the effect of the ERAS pain management method in managing pain after surgery in patients with extremity soft tissue sarcoma. Enhanced Recovery After Surgery, or ERAS, is a pain management method that places emphasis on managing risk factors (things like smoking, nutrition and fitness), using multiple types of pain control, and early movement, with the goal of improving patient outcomes. ERAS has been shown to reduce the length of time some patients stay in the hospital, reduce complications from surgery, and even lower costs of some surgeries. ERAS is designed may help cut down on the use of these narcotics in managing the pain of surgery patients. The purpose of this trial is to demonstrate that ERAS is safe and effective for patients having surgery to treat their sarcoma. Specifically, this study will look at using a non-narcotic pain management program that includes other methods of managing the pain of sarcoma surgery patients.
Sarcoma
N/A
Lawrenz, Joshua
NCT04461171
VICCSAR2020

Evaluation of Patient Reported Outcomes in Patients with Digestive System and Lung Neuroendocrine Cancer, NET-PRO study

Gastrointestinal

This study evaluates the patient reported outcomes in patients with digestive system neuroendocrine cancer and lung neuroendocrine cancer. Patients with neuroendocrine cancer usually have a high symptom burden which may have a negative effect on health-related quality of life (HRQoL). Patient questionnaires gather information describing symptoms and effect on quality of life, cancer type and any treatments received. Studying quality of life in patients receiving treatment for neuroendocrine cancers may help identify the effects of treatment and improve future treatment plans. Information gathered from this study may help researchers understand whether patient's diagnosis, symptoms, and order of cancer treatments have any effect on quality of life.
Gastrointestinal
N/A
Ramirez, Robert
NCT05064150
VICCGI2247

Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study

This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.

By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.

This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
N/A
Kitko, Carrie
NCT04372524
VICCPED2183

cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease

Miscellaneous

This is an observational case-control study to train and validate a genome-wide methylome
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.

Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
Miscellaneous
N/A
Rini, Brian
NCT05366881
VICCMD21111

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Multiple Cancer Types

In this observational study researcher want to learn more about the effectiveness of drug
VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use
in patients with TRK fusion cancer which is locally advanced or spread from the place where
it started to other places in the body. TRK fusion cancer is a term used to describe a
variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic
Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or
fuses, with a different gene. This joining results in the activation of certain proteins (TRK
fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an
approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult
and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the
decision to treat their disease with VITRAKVI has been made by their treating physicians.
During the study, patients' medical information such as treatment information with VITRAKVI,
other medication or treatments, changes in disease status and other health signs and symptoms
will be collected within the normal medical care by the treating doctor. Participants will be
observed over a period from 24 to 60 months.
Pediatric Solid Tumors, Pediatrics
N/A
Borinstein, Scott
NCT04142437
VICCPED2071

Studying Health Outcomes after Treatment in Patients with Retinoblastoma, RIVERBOAT Study

Multiple Cancer Types

This trial studies health outcomes after treatment in patients with retinoblastoma. Gathering health information over time from patients and family members through vision assessments, samples of tissue and saliva, and questionnaires may help doctors learn more about what causes retinoblastoma, identify long-term health outcomes for patients with retinoblastoma, and find out which therapies may be the best for treating retinoblastoma.
Pediatrics, Retinoblastoma (Pediatrics)
N/A
Friedman, Debra
NCT03932786
VICCPED1878

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