Breast CancerNCT01705561
Evaluation of Attitudes About Fertility
An observational study of Breast Cancer, run by Grupo de Estudios Clínicos Oncológicos Peruano at 2 sites in Peru.
Trial summary
Assess the attitudes and feelings of premenopausal Latin American women towards the risk of loss their fertility by adjuvant chemotherapy. Correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 450 participants
- Where
- 2 sitesPeru
- Study dates
- Dec 2012to Jun 2013
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: women with diagnosis of breast cancer in pre menopausal status
Who may be able to join
- women with breast cancer diagnosis in premenopausal
- over 18 years
- signed informed consent
Who cannot join
- Evidence of infertility at diagnosis
Trial locations and contacts
2 sites in 1 country.
Peru2 sites
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima Province, 34
HENRY GOEMZ, DR, +5112016500 ext. 2260, hgomez@gecoperu.org
HENRY L GOMEZ, DR
Oncosalud
Lima, Lima Province, 41
ALFREDO AGUILAR, MD, +5137900, aac@oncosalud.pe
Alfredo Aguilar, MD
About this study
Official title: Evaluation of Attitudes of Premenopausal Latin American Patients With Breast Cancer Towards the Risk of Loss Their Fertility by Chemotherapy
- Assess the attitudes and feelings of premenopausal Latin American women towards the risk of loss their fertility by adjuvant chemotherapy.
- Correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual cycle.
Read the detailed description
Eligibility criteria:
- Latin American women with evidence of cancer diagnosis at premenopausal status
- Over 18 years
- Agree to sign the informed consent
- No evidence of infertility.
- Conditions
- Breast Cancer
- Keywords
- fertility, chemotherapy, breast cancer, latin american women, pre menopausal
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startDec 2012
- Study completionJun 2013 (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.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo de Estudios Clínicos Oncológicos Peruano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HENRY L GOMEZ, DR, Principal investigator, Grupo de Estudios Clínicos Oncológicos Peruano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705561
- Sponsor's protocol ID
- GECOPERU 01-2012
- Status last verified
- Oct 2012
- First submitted
- 10 Oct 2012
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Attitudes of Premenopausal Latin American Patients With Breast Cancer Towards the Risk of Loss Their Fertility by Chemotherapy
- ClinicalTrials.gov ID
- NCT01705561
- Acronym / sponsor ID
- GECOPERU 01-2012
- Conditions
- Breast Cancer
- Keywords
- fertility, chemotherapy, breast cancer, latin american women, pre menopausal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Grupo de Estudios Clínicos Oncológicos PeruanoUniversity, hospital or other
- Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- Study start
- Dec 2012
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 Oct 2012 (estimated)
- 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.
- Assess the attitudes and feelings of premenopausal Latin American women towards the risk of loss their fertility by adjuvant chemotherapy.
- Correlate the attitudes with other variables including age at diagnosis, already having children, number of children, level of instruction, marital status, frequency of menstrual cycle.
Detailed description
Eligibility criteria:
- Latin American women with evidence of cancer diagnosis at premenopausal status
- Over 18 years
- Agree to sign the informed consent
- No evidence of infertility.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with diagnosis of breast cancer in pre menopausal status
Key inclusion criteria (3 listed)
- women with breast cancer diagnosis in premenopausal
- over 18 years
- signed informed consent
Key exclusion criteria (1 listed)
- Evidence of infertility at diagnosis
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2012.
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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.
HENRY L GOMEZ, DR principal investigator
Grupo de Estudios Clínicos Oncológicos Peruano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Grupo de Estudios Clínicos Oncológicos Peruano at 2 sites in Peru.
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 3 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 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 15 Oct 2012.