Registry Study of Pregnancy and Breast Cancer

NCT04603820 | Active Not Recruiting

• 1 other identifier: GEICAM/2017-07
• Study Type: observational
• Target: 866
• Locations: 1 country
• Sites: 28

Brief Summary

An ambispective observational registry study of pregnancy and breast cancer

Conditions

Breast Cancer and Pregnancy

Keywords

Pregnancy; Gestational breast cancer; Fertility preservation technique; Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment

  Data for this study will be recorded into the electronic case report form (eCRF) via web using Remote Data Capture (RDC) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned. Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.

  Baseline visit

• Race of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment

  Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned. Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.

  Baseline visit

• Age of participants with breast cancer diagnosis during the gestation, breastfeeding, first year after the delivery (not during breastfeeding period), after a pregnancy and followed by any fertility preservation method before the anticancer treatment

  Data for this study will be recorded into the eCRF via web using RDC (Remote Data Capture) from Oracle Clinical®. Once patient has signed the ICF or verified that the data of deceased patients can be included, designated site personnel will complete the register of each patient in the eCRF, where an identification number will automatically be assigned. Data will be recorded in the eCRF at the time of patient enrollment and approximately every year.

  Baseline visit

Secondary Outcomes (19)

• Clinicopathological characteristics of cancer: Tumor size

  3 years

• Clinicopathological characteristics of cancer: lymph node condition

  3 years

• Clinicopathological characteristics of cancer: metastasis presence

  3 years

• Clinicopathological characteristics of cancer: histopathological differentiation degree

  3 years

• Clinicopathological characteristics of cancer: hormonal receptor status

  3 years

Other Outcomes (1)

• Potential relationship of clinical activity biomarkers and the probability of developing gestational breast cancer or having a relapse after the pregnancy

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer in any of these three situations: 1. Patients with gestational breast cancer, defined as breast cancer diagnosed during pregnancy, breastfeeding or up to a year after delivery. 2. Patients who become pregnant after a breast cancer diagnosis. 3. Patients with breast cancer who have followed any fertility preservation technique prior to the start of breast cancer treatment.

You may qualify if:

• The patient should have signed and dated the informed consent form (ICF). The enrollment of patients who have died is allowed.
• Women aged ≥ 18 years.
• Patients in one of the following situations:
• Patients with breast cancer diagnosis during pregnancy, breastfeeding or within the year after delivery.
• Patients with breast cancer who become pregnant after treatment.
• Patients with breast cancer who were subjected to any fertility preservation method prior to the start of breast cancer treatment.
• The patients referred to in the previous section and the patients who meet these characteristics prospectively could be enrolled retrospectively upon registry opening.
• All cases diagnosed at the same site may be included. In order to prevent duplications, in case the patient followed her treatment and follow-up at another site, she will be enrolled as per the site where the diagnosis was made, requesting information of the treatment and progression, when possible.
• Availability of clinical, epidemiological and progress data.

You may not qualify if:

• Patients who do not wish to participate in the study for any reason could not be included in the study.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead

Study Sites (28)

Hospital Unviersitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Universitario de Basurto

Bilbao, Bizkaia, 48013, Spain

Location

Hospital Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Complejo Hospitalario de Galicia (CHUAC)

A Coruña, La Coruña, 15009, Spain

Location

Hospital Universitario Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital General Universitario de Albacete

Albacete, 02006, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Location

Complejo Hospitalario Reina Sofía

Córdoba, 14004, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Virgen de la Salud de Toledo

Toledo, 45004, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politecnic La Fè

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

A whole blood sample will be collected from all patients enrolled preferably at the enrollment visit (after signing the ICF).

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Study Director

  Instituto Valenciano de Oncología, Valencia, España

  STUDY DIRECTOR

• Study Director

  Hospital Universitario Reina Sofía de Córdoba, Córdoba, España

  STUDY DIRECTOR

• Study Director

  Hospital Clínico Universitario de Valencia, Valencia, España

  STUDY DIRECTOR

• Study Director

  Centro Nacional de Epidemiología. Instituto de Salud Carlos III, Madrid, España

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: October 27, 2020
• Study Start: November 18, 2019
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

ES (28)