Evaluation of Pregnancy Associated Plasma Protein A (PAPP... | NCT06174571

Studies
Evaluation of Pregnancy Associated Plasma Protein A (PAPPA) as a Biomarker in Breast Cancer.

NCT06174571

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 18, 2023Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

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

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Estimated

Primary Completion Date

Feb 1, 2026Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Dec 2, 2023

First Submission Date that Met QC Criteria

Dec 8, 2023

First Posted Date

Dec 18, 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 8, 2023

Last Update Posted Date

Dec 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 work aims to:

Evaluation of the role of pregnancy associated plasma protein A( PAPPA ) in diagnosis & early detection of breast cancer.
Evaluation of the relationship between ( PAPPA ) levels and stages of breast cancer.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		patients diagnosed with breast cancer at different stages of the disease.
2		apparently healthy females as a control group.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quantitative measurement of pregnancy associated plasma protein A in female patients with breast cancer.	Quantitative measurement of pregnancy associated plasma protein A in female patients with breast cancer.	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

female patients with breast cancer who were diagnosed by histopathological studies and did not receive any treatment.

Exclusion Criteria:

Patients who received chemotherapy or radiotherapy.
Patients with known other organ malignancy.

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

female patients with breast cancer at different stages of the disease.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aya Hasan Abdulhady	Contact	01146471617		ayahhasan99@gmail.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided