Blood Pressure Measurement for Metastatic Medullary Thyroid Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Medullary Thyroid Carcinoma+8 MoreBlood Pressure Measurement - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Metastatic Medullary Thyroid Carcinoma
  • Chronic Kidney Disease
  • Stage IV Thyroid Gland Medullary Carcinoma
  • Cardiovascular Disease
  • Stage IVC Medullary Thyroid Carcinoma
  • Kidney Cancer
  • Stage IVA Thyroid Gland Medullary Carcinoma
  • Stage IV Renal Cell Carcinoma
  • Stage IVB Thyroid Gland Medullary Carcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 6 months

Up to 6 months
Bronchial Provocation Tests
Pharmaceutical Preparations
Differences in symptoms and health-related quality of life
Bronchial Provocation Tests
Frequency of automated home SBP measurements > 180 mmHg or < 90 mmHg or diastolic (D)BP > 110 mmHg
Incidence of significant cardiovascular (CV) events
Participant satisfaction with BP care
Patient-rated adverse events associated with hypertension, hypotension and anti-hypertensive medications
Provider satisfaction with BP care
Study retention rates

Trial Safety

Trial Design

2 Treatment Groups

Arm B (usual blood pressure management)
1 of 2
Arm A (intensive systolic blood pressure management)
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Blood Pressure Measurement · No Placebo Group · N/A

Arm A (intensive systolic blood pressure management)Experimental Group · 4 Interventions: Quality-of-Life Assessment, Blood Pressure Measurement, Questionnaire Administration, Clinical Management · Intervention Types: Other, Other, Other, Other
Arm B (usual blood pressure management)ActiveComparator Group · 3 Interventions: Best Practice, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Other, Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
103 Previous Clinical Trials
171,975 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,141,584 Total Patients Enrolled
Bonnie KyPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically or cytologically-proven advanced metastatic renal cell cancer (mRCC) or medullary thyroid cancer
You have chronic kidney disease (defined as an estimated glomerular filtration rate [eGFR] between 30 and 60 ml/min per 1.73 m^2).
You have been exposed to another AA-TKI or immunotherapy.
You have a 10% or greater risk of heart disease.
You have systolic blood pressure (SBP) ≥ 130 mmHg on two or more occasions in the 12 weeks prior to or during the first 4 weeks of treatment with an AA-TKI.
A patient with a single elevated SBP ≥ 130mmHg should be assessed for eligibility.