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PregnancyPregnancyNCT02774915

Outcome of Pregnancy and Breast Cancer

An observational study of Pregnancy and Breast Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Investigators are interested to explore the clinical and pathological characteristics of breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during pregnancy, median gestational age at diagnosis, the level of the tumor differentiation patients present with, during pregnancy, and the… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Pregnancy, Breast Cancer
How many people
20 participants
Where
1 siteSaudi Arabia
Study dates
Nov 2014to Nov 2019
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: The study design approach is a cohort study, which planned to recruit all patients attend the breast cancer clinic, interview in details, assessed and followed prospectively for 5 years from the time of diagnoses or till death occurs, whichever occurred first.

Who may be able to join

  • All pregnants with breast cancer will be included in this study

Who cannot join

  • Refusal of pregnant women with 2nd or 3rd trimester to receive chemotherapy, will be excluded

Trial locations and contacts

1 site in 1 country.

Nagham Sheblaq contact

oncologyresearch@ngha.med.sa

Saudi Arabia1 site, 1 recruiting
  • King Abdul Aziz Medical City for National Guard Health Affairs

    Riyadh, 11426

    Omalkhair Abulkhair, MD, 0096612520088 ext. 141077, abulkhairo@ngha.med.sa

    Oncology Research, 0096612520088 ext. 14601, oncologyresearch@ngha.med.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Outcome of Pregnancy Associated Breast Cancer (PABC) in Saudi Arabia ; Prospective Cohort Study.

Investigators are interested to explore the clinical and pathological characteristics of breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during pregnancy, median gestational age at diagnosis, the level of the tumor differentiation patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan to collect prospective quality research databases that could provide further important information concerning this condition and serve in both short- and long-term sequelae in mother and fetus.

Read the detailed description

Breast cancer is classified as pregnancy-associated if it is diagnosed during pregnancy or within one year of delivery . About 3% of all breast cancers are diagnosed during pregnancy . The average age at diagnosis for patients with PABC is 32-38 years .A painless mass is palpated by the patient in 90% of reported cases .The incidence of breast cancer is the same in pregnant women as nonpregnant women in the general population.

Breast cancer is the most common malignancy affecting women world wide. More than one million cases diagnosed annually. One in ten of all new cancers diagnosed worldwide each year is a cancer of the female breast, and it is the most common cancer in women in both developing and developed areas. It is also the principal cause of death from cancer among women globally. Similar applied to Saudi Arabia. More over, cancer registry suggested an increase in incidence over the years with median age of 67 years old. The same applied for other Arab regions. Recently, women in Arab regions postpone their first pregnancy which may increase the risk for pregnancy associated breast cancer.

The physiologic changes that take place in the breast during pregnancy can contribute to a delay in the diagnosis of PABC. In preparation for lactation, a women's breast size will nearly double in size and weight. The influence of estrogen and progesterone cause an increase in blood flow and fat, resulting in an increase in the size of milk-producing glands. Some women may begin to leak colostrum by 25 weeks gestation. Irritation of the breast ducts caused by rapid tissue growth may cause a bloody discharge, which usually is a benign condition. The areola also may increase in size and become darker in color. In addition, Montgomery tubercles, small nodules surrounding the areola, will produce a fluid to lubricate and cleanse the nipple in preparation for nursing.

Breast cancer associated with pregnancy presents to the clinician with particular challenges at diagnosis and management level. The diagnosis may be delayed and difficult owing to the physiological changes within the breast and limitations on investigations. Moreover once a diagnosis has been confirmed and staging completed, options for treatment will be influenced by the need to give optimal treatment to the mother whilst minimizing risks to the fetus. The particular challenges faced both in the initial diagnosis and management of women with pregnancy-associated breast cancer will be assessed in this study.

Recent studies suggest that, when matched for age and stage, the prognosis of pregnancy-associated breast cancer is comparable to non-pregnancy-associated breast cancer. However, the risk for breast cancer recurrence associated with subsequent pregnancies in this population is not clear. Although there is data showing no increase in the risk of recurrence for women who become pregnant after breast cancer treatment, pregnancy-associated breast cancer may be a distinct clinical category where subsequent pregnancies after treatment may confer an increased risk of recurrent disease9.

There is a lack of controlled data concerning the management of pregnancy-associated breast cancer, both locally and globally.

Investigators plan in this study to assess and document the clinical presentation, diagnosis, treatment, prognostic factors, and routine clinical management of pregnant ladies diagnosed with breast cancer in Saudi Arabia. Data base through data collection on all information related to breast cancer patients with pregnancy will be performed across detailed interview and chart review at all specialized clinic in the National Guard. All patients seen within the coming 5 years will be enrolled in this study.

Investigators are interested to explore the clinical and pathological characteristics of breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during pregnancy, median gestational age at diagnosis, the level of the tumor differentiation patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan to collect prospective quality research databases that could provide further important information concerning this condition and serve in both short- and long-term sequelae in mother and fetus.

Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To explore the characteristics of pregnancy associated breast cancer (PABC), maternal and fetal outcome of the pregnancy.

    Measured: 5 years

  2. Prevelance and outcome

    • To determine the prevalence and incidence of breast cancer in pregnancy

    Measured: 5 years

  3. prevalence and outcome

    • To measure the prognostic outcomes of at mother and fetus level in breast cancer with pregnancy

    Measured: 5 years

  4. prevalence and outcome

    • To describe the pathological characteristics of breast cancer when it concomitantly present with pregnancy

    Measured: 5 years

  5. prevalence and outcome

    • To assess the sensitivity and specification of diagnostic procedure.

    Measured: 5 years

Secondary outcomes (2)
  1. Long outcome

    • To measure the outcome of newborn after 1st and 5th year.

    Measured: 5 years

  2. Long outcome

    • To assess the outcome of breast cancer after 5 years from diagnosis

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2019 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02774915
Sponsor's protocol ID
RC12/153/R
Acronym
Pregnancy
Status last verified
May 2016
First submitted
31 Mar 2016
Last updated
17 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Breast Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.

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 1 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Nagham Sheblaq (oncologyresearch@ngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To explore the characteristics of pregnancy associated breast cancer (PABC), maternal and fetal outcome of the pregnancy. (time frame: 5 years). The study lists 5 primary outcomes in all. 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 17 May 2016.

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