Determining Beta-hCG Levels in Patients Through Alternati... | NCT06178224

Studies
Determining Beta-hCG Levels in Patients Through Alternative Sample Types

NCT06178224

Sponsor

Simple HealthKit

Status

Completed

Last Update Posted

Dec 20, 2023Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Pregnancy Related
Abortion

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2022Actual

Primary Completion Date

Apr 19, 2023Actual

Completion Date

Jun 23, 2023Actual

First Submitted Date

Nov 29, 2023

First Submission Date that Met QC Criteria

Dec 11, 2023

First Posted Date

Dec 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2023

Last Update Posted Date

Dec 20, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Simple HealthKitINDUSTRY

Collaborators

Name	Class
Planned Parenthood Federation of America	OTHER
Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to determine if there is any quantifiable correlation between serum beta hCG and dried blood spot (DBS) beta hCG levels. This data will be used to develop a less invasive collection method to determine quantitative hCG levels.

Detailed Description

A cohort of 40 individuals at various stages of pregnancy or medical abortion will be recruited for the study. Each participant will provide biospecimens that include the following: serum, saliva, urine, and dried blood spot (DBS). These samples will be collected and stored at the clinic under appropriate storage conditions until they can be shipped, under dry ice, to the testing lab. Once samples arrive at the lab, serum samples will be thawed and prepared to run on an ECL analyzer to determine reference beta hCG values in mIU/mL for each participant.

Samples will be run as they are received by the lab. The initial 10-12 samples will be used to evaluate study feasiblility and determine if there is one sample type that performs better than the others. The other matched sample types will be processed and run on the ECL analyzer. The values for beta hCG mIU/mL of the other sample types will then be compared to the matched serum to determine if there are any consistent correlations.

In the first 10-12 samples, if one sample type is shown to perform better than the others, the study will shift focus towards prioritizing the analysis of that particular sample type in regards to correlation with serum. If more than one sample type is shown to perform well, then those sample types will be equally prioritized. If no sample type shows any correlation, the study will end.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants (qualified)		This arm consists of participants who are able to collect all sample types No intervention is administered

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of matched serum and DBS samples for detection of beta hCG levels using an ECL analyzer.	It was determine that serum and DBS samples show a consistent correlation. DBS beta hCG levels can be converted to reflect those of serum beta hCG. By utilization of a dilution factor, DBS beta hCG levels matched that of serum beta hCG levels with an average accuracy of 94.8%. Serum samples were run on an analyzer to obtain reference values in mIU/mL. Dried blood spot (DBS) samples, that were matched for both time of collection and patient, were extracted with an elution buffer coupled with agitation. This eluate was run on the same analyzer as the serum samples and the resulting beta hCG levels in mIU/mL were corrected with a dilution factor and compared to the serum reference values.	2-24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are at least 18 years old
Have not taken antibiotics in the last 21 days
Are here for services related to a current or recent pregnancy
Agree to provide all required samples
Have not previously participated in this study

Exclusion Criteria:

Are under18 years old
Have taken antibiotics in the last 21 days
Are not here for services related to a current or recent pregnancy
Disagree or unable to provide all required samples
Have previously participated in this study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The study population will consists of individuals who are of 18 years or older that are currently pregnant or undergoing medical abortion. All of the participants will come from affiliated Planned Parenthood clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erin Berry, MD	Planned Parenthood Great Northwest, Hawai'I, Alaska, Indiana, Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Planned Parenthood of the Great Northwest, Hawai'i, Alaska, Indiana and Kentucky		Tacoma	Washington	98405	United States