Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03479437
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2018-03-12
Brief Title:
The TEMPO Tracing the Effect of the MC4 Pathway in Obesity Registry
Sponsor:
Rhythm Pharmaceuticals Inc
Organization:
Rhythm Pharmaceuticals Inc
Study Overview
Official Title:
The TEMPO Tracing the Effect of the MC4 Pathway in Obesity Registry Involving Variants in Hypothalamic Genes Upstream or Downstream From the Melanocortin-4 Receptor MC4R
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A voluntary prospective study that will allow registration and follow-up of individuals with MC4R pathway genetic obesity
Detailed Description:
Potential patients will be referred to coordinating centers by their healthcare provider treating physician diagnosing physician or primary care physician and if eligible will be invited to enroll in the registry The Registry Coordinating Center will be responsible for obtaining consent from adult patients and caregivers of minor patients as well as assent from minors when appropriate screening patients and enrolling them in the registry
The registry will capture data entered by the patient the patients healthcare provider and the patients caregiver using online electronic survey tools administered at baseline and annually thereafter The patients healthcare provider will complete the baseline Healthcare Provider survey tool reporting the patients baseline demographics medical history clinical information and disease characteristics The patient and caregiver will complete their dedicated baseline survey tools answering questions on the impact of disease on their everyday life Survey tools include questions on patient and caregiver demographics patient physical activity patient food and hunger episodes patient quality of life and caregivers perspective of disease burden on the family Registry patients caregivers and healthcare providers will be contacted annually approximately every 12 months by the Registry Coordinating Center to complete an online follow-up survey tool including a smaller subset of questions from the baseline survey tools
The registry will capture data entered by the patient the patients healthcare provider and the patients caregiver using online electronic survey tools administered at baseline and annually thereafter The patients healthcare provider will complete the baseline Healthcare Provider survey tool reporting the patients baseline demographics medical history clinical information and disease characteristics The patient and caregiver will complete their dedicated baseline survey tools answering questions on the impact of disease on their everyday life Survey tools include questions on patient and caregiver demographics patient physical activity patient food and hunger episodes patient quality of life and caregivers perspective of disease burden on the family Registry patients caregivers and healthcare providers will be contacted annually approximately every 12 months by the Registry Coordinating Center to complete an online follow-up survey tool including a smaller subset of questions from the baseline survey tools
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None