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Blood Pressure Management for Kidney and Thyroid Cancer

N/A
Waitlist Available
Led By Bonnie Ky
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with a history of hepatitis C virus (HCV) infection must have been treated and cured
Patient must have either clinical cardiovascular (CV) disease or evidence of increased CV risk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial looks at the effects of intensive blood pressure management in patients with metastatic kidney or thyroid cancer who are starting anti-angiogenic therapy.

Who is the study for?
This trial is for adults with metastatic kidney or thyroid cancer who are starting anti-angiogenic tyrosine kinase inhibitor therapy. They must have cardiovascular disease or risk, chronic kidney disease with specific blood filtration rates, and controlled hepatitis if present. Participants need to be able to monitor their blood pressure at home, use contraception if necessary, and have internet access.Check my eligibility
What is being tested?
The CARISMA study is testing whether intensive management of systolic blood pressure (target less than 120 mmHg) using home monitoring and medication adjustments provides benefits over usual care (target less than 140 mmHg) in patients taking cancer drugs that inhibit blood vessel growth.See study design
What are the potential side effects?
Potential side effects may include changes in blood pressure levels due to the intensive management approach. The study does not introduce new medications but focuses on managing existing treatment side effects more aggressively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but have been treated and cured.
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I have heart disease or am at high risk for heart problems.
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My kidney function is reduced but not severely (moderate CKD).
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I am using or willing to use effective birth control or abstain from sex.
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My brain scans show no cancer growth after treatment for brain metastases.
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My cancer is advanced kidney or thyroid cancer treated first with specific cancer drugs.
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My hepatitis B virus load is undetectable with treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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I have been treated with an AA-TKI before.
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I have another cancer that won't affect this trial's treatment.
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I have received immunotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bronchial Provocation Tests
Secondary outcome measures
Bronchial Provocation Tests
Pharmaceutical Preparations
Differences in symptoms and health-related quality of life
+5 more
Other outcome measures
Incidence of significant cardiovascular (CV) events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (intensive systolic blood pressure management)Experimental Treatment4 Interventions
Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks, and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).
Group II: Arm B (usual blood pressure management)Active Control3 Interventions
Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks, and upload the recorded blood pressures to a central monitoring team.

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
115 Previous Clinical Trials
176,761 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,585 Total Patients Enrolled
Bonnie KyPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Intensive Blood Pressure Management (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04467021 — N/A
Thyroid Carcinoma Research Study Groups: Arm B (usual blood pressure management), Arm A (intensive systolic blood pressure management)
Thyroid Carcinoma Clinical Trial 2023: Intensive Blood Pressure Management Highlights & Side Effects. Trial Name: NCT04467021 — N/A
Intensive Blood Pressure Management (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04467021 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous centers hosting this research inside the city limits?

"In addition to Aurora Sinai Medical Centre in Milwaukee, Wisconsin and two other medical centres within the state, this study is also recruiting participants from 24 additional sites across the nation."

Answered by AI

How many individuals are being accepted into this scientific experiment?

"This medical trial necessitates the inclusion of 60 qualified individuals. People in Milwaukee, Wisconsin and Racine, Missouri are eligible to partake at Aurora Sinai Medical Center and Aurora Cancer Care-Milwaukee respectively."

Answered by AI

Is there still capacity to join this research protocol?

"Clinicaltrials.gov shows that this medical research is still in search of suitable participants. The initial posting was on the 1st of September 2020, and it has recently been revised as of the 10th August 2022."

Answered by AI
~4 spots leftby Jun 2024