CClinicalTrials.gg
Status unknownNCT03322176Updated Jan 23, 2019

Healthcare Decisions Post-Testing, Risk-reducing and Preventative Strategies Using LYNCH Genetic Testing Reducing, and Preventative Strategies Using LYNCH Genetic Testing

An observational study in Colon Cancer and Endometrial Cancer, sponsored by Data Collection Analysis Business Management. Status unknown at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Data Collection Analysis Business Management · Observational

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 64 Years
Sex
All
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Study summary

Increase surveillance for LYNCH Syndrome

Read the detailed description

The purpose of this minimal risk, observational survey is to increase surveillance for Lynch Syndrome (hereditary non-polyposis colon cancer), Colorectal, and Endometrial cancer, also to determine targeted risk-reducing and preventative strategies.

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Conditions studied

  • Colon Cancer
  • Endometrial Cancer
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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on Lynch genetic testing and changes made to their specific SOP.

Inclusion criteria

  • Must be a Medical Practitioner

    • Medical Doctor (MD)
    • Doctor of Osteopathic (DO)
    • Physician Assistant (PA)
    • Advanced Practice Registered Nurse (APRN)
    • Nurse Practitioner (NP)
  • Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history.

Exclusion criteria

Exclusion Criteria:

  • Government-funded insurance data cannot be included in the study.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • OtherGenetic testing

    LYNCH genetic testing

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What researchers measure

Primary outcomes

  1. Provider Structures and Processes

    Plan of Care Changes due to LYNCH genetic testing. Provider based observational survey system on the health and well-being of patients and populations

    Time frame: 36 months

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Study locations

1 site
  • DCABM
    Land O' Lakes, Florida 33558, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03322176
Lead sponsor
Data Collection Analysis Business Management
Collaborators
PAS Research Services
Responsible party
Sponsor
First posted
Oct 26, 2017
Start date
Oct 17, 2017
Primary completion
Oct 17, 2020 (estimated)
Completion
Nov 1, 2020 (estimated)
Last update
Jan 23, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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