NCT04195048

Brief Summary

Stroke is a part of circulatory diseases which are the primary cause of death in Egypt. It accounts 14% of all deaths thus ranks the 2nd after ischemic heart disease. Cancer accounts 9% of population mortality in Egypt. Nearly 108,600 Egyptians newly diagnosed with cancer each year. The interrelationship between stroke and cancer is complex. Cancer may directly or indirectly lead to stroke via: hypercoagulability, nonbacterial thrombotic endocarditis (NBTE), direct tumor compression of blood vessels or treatment-related effects which potentiate stroke. The risk of ischemic stroke after chemotherapy is largely increased by the use of certain types of chemotherapy not only by cancer histologic type. Brain infarction usually a subsequent complication appears sometimes shortly after chemotherapy. Chronic radiation vasculopathy that affects medium and large intra- and extra-cranial arteries is characterized by increasing rates of hemodynamic significant stenosis with time after radiotherapy. The study aims to clarify the relation between cancer and its treatment with ischemic stroke by discussing the different mechanisms by which a vascular insult happen causing neurological deficit. The study provides more information about cancer patients with higher risk to develop ischemic stroke more than other patients by identifying co morbidities and dosage of cancer treatment that causes cerebrovascular insults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

December 9, 2019

Last Update Submit

December 9, 2019

Conditions

Keywords

Ischemic Stroke, Cancer

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.

    6 months

Study Arms (2)

Cancer patients with acute ischemic stroke

Eighty patients previously or currently suffering from manifest cancer on or not on cancer treatment who developed stroke

Other: Risk factors

Control patients with acute ischemic stroke without cancer

Eighty patients with acute ischemic stroke without cancer

Other: Risk factors

Interventions

Risk factors: modifiable and unmodifiable risk factors

Cancer patients with acute ischemic strokeControl patients with acute ischemic stroke without cancer

Eligibility Criteria

Age25 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Retrospective study was conducted on patients diagnosed with cancer receiving chemotherapy or radiotherapy to evaluate the relation between cancer or cancer therapies and ischemic stroke development. * Patients had been recruited from the oncology center, nuclear medicine department and neurology department in Mansoura University and private centers.

You may qualify if:

  • patients previously or currently suffering from manifest cancer on or not on cancer treatment who developed stroke
  • control patient with ischemic storke without cancer

You may not qualify if:

  • Patients developed cerebrovascular insults prior to the onset of cancer
  • Cancer patients with symptoms mimic stroke.
  • Cancer patients with focal neurological deficit due to direct effect of malignant tumor.
  • Patients missed their follow up.
  • Patients with traditional cerebrovascular risk factors such as (hypertension, hyperlipidemia, diabetes and atrial fibrillation) prior to cancer diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Ischemic StrokeNeoplasms

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Esmael M Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

November 1, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations