Breast CancerNCT06174571
Evaluation of Pregnancy Associated Plasma Protein A (PAPPA) as a Biomarker in Breast Cancer.
An observational study of Breast Cancer, run by Assiut University.
Trial summary
This work aims to: 1. Evaluation of the role of pregnancy associated plasma protein A( PAPPA ) in diagnosis \& early detection of breast cancer. 2. Evaluation of the relationship between ( PAPPA ) levels and stages of breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
Study population: female patients with breast cancer at different stages of the disease.
Who may be able to join
- female patients with breast cancer who were diagnosed by histopathological studies and did not receive any treatment.
Who cannot join
- Patients who received chemotherapy or radiotherapy.
- Patients with known other organ malignancy.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients diagnosed with breast cancer at different stages of the disease. | |
| 2 | apparently healthy females as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Hassan Abdulhady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174571
- Sponsor's protocol ID
- PAPPA & breast cancer
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pregnancy Associated Plasma Protein A (PAPPA) as a Biomarker in Breast Cancer.
- ClinicalTrials.gov ID
- NCT06174571
- Acronym / sponsor ID
- PAPPA & breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients diagnosed with breast cancer at different stages of the disease. |
| 2 | – | –apparently healthy females as a control group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- female patients with breast cancer at different stages of the disease.
Key inclusion criteria (1 listed)
- female patients with breast cancer who were diagnosed by histopathological studies and did not receive any treatment.
Key exclusion criteria (2 listed)
- Patients who received chemotherapy or radiotherapy.
- Patients with known other organ malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative measurement of pregnancy associated plasma protein A in female patients with breast cancer.
Time frame: baseline
Quantitative measurement of pregnancy associated plasma protein A in female patients with breast cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Hasan Abdulhady (01146471617, ayahhasan99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measurement of pregnancy associated plasma protein A in female patients with breast cancer. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.