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NCT Number: NCT05733416

Intensive Cancer Screening After Cryptogenic Stroke

The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial to determine whether an occult cancer screening strategy of FDG PET/CT (F-fluorodeoxyglucose positron emission/computed tomography) in addition to usual care increases the number of occult cancers diagnosed after screening compared to usual care cancer screening alone in patients with cryptogenic stroke.

Recruiting

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Key information

Conditions

Occult Cancer Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location status: Recruiting

Location contact

Dariush Dowlatshahi, MD PhD

PRINCIPAL_INVESTIGATOR

Deborah Siegal, MD

PRINCIPAL_INVESTIGATOR

Michele Demetroff

CONTACT

[email protected]

6137985555

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults ≥18 years
  • presenting to the Ottawa Hospital Stroke Prevention Clinic or the Ottawa Hospital Neurovascular Unit with a first cryptogenic ischemic stroke after advanced evaluation as per American Heart Association guidelines and Saver approach (maximum 3 months after stroke)
  • patient or delegate willing and able to provide informed consent.

Exclusion criteria

  • contraindications to FDG PET/CT (pregnancy or unable to lie still in bed for 20 minutes)
  • active cancer or previous cancer diagnosis (other than basal or squamous cell carcinoma of the skin)

Treatment and study plan

FDG PET/CT

Diagnostic Test

F-fluorodeoxyglucose positron emission/computed tomography

Usual Care

Diagnostic Test

Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care

Primary outcomes

  1. Participant Recruitment

    Time frame: Over 12 months

    Number of participants recruited

Secondary outcomes

  1. Eligibility Rate

    Time frame: Over 12 months

    percentage of screened patients who are eligible

  2. Consent Rate

    Time frame: Over 12 months

    percentage of eligible patients who provide consent

  3. Retention Rate

    Time frame: Over 24 months

    percentage of participants retained at follow-up

  4. Study Completion Rate

    Time frame: Over 24 months

    percentage of participants who completed all study procedures

  5. Adherence Rate

    Time frame: Over 24 months

    adherence to screening strategy

Other outcomes

  1. Screening time frame

    Time frame: Over 24 months

    time from diagnosis to screening

  2. Reasons for participation

    Time frame: Over 24 months

    Reasons for accepting/declining participation

  3. Usual care cancer screening strategies

    Time frame: Over 24 months

    Usual care cancer screening strategies ordered by treating physicians

Study contacts

Contact information is provided by the study sponsor or research team.

Dariush Dowlatshahi, MD PhD

CONTACT

[email protected]

613-798-5555 ext. 14709

Deborah Siegal, MD

CONTACT

[email protected]

613-737-8899 ext. 78060

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Brain Canada
  • Canadian Stroke Consortium (CSC)
  • Heart and Stroke Foundation of Canada

Registry information

Official study title

Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial

Acronym: INCOGNITO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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