乳腺癌、生育力的临床试验-临床试验注册中心-ICH GCP

研究概览

地位

完全的

条件

详细说明

To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:

Age at diagnosis
Number of children
Will of having children
Marital status
Scholarity
Period of time from the diagnosis
Time of the last menstruation period
Chemotherapy administration
Clinical staging at the diagnosis
Pathological evaluation
Documentation of the cancer therapy

研究类型

观察性的

注册 (实际的)

343

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

古巴
- - Havana、古巴
    - Instituto Nacional de Oncologia y Radiobiologia
墨西哥
- - Toluca de Lerdo、墨西哥
    - Cenro Oncologico Estatal ISSEMYM
委内瑞拉
- - Puerto Cabello、委内瑞拉
    - Hospital de Clínicas San Agustín
巴西
- - São Paulo、巴西
    - Hospital Perola Byington
- Rio Grande Do Sul
  - Porto Alegre、Rio Grande Do Sul、巴西
    - CPO - Pucrs
  - Porto Alegre、Rio Grande Do Sul、巴西
    - HCPA
秘鲁
- - Surquillo、秘鲁
    - INEN

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 40年 (成人)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Pre menopausal women diagnosed with breast cancer prior treatment

描述

Inclusion Criteria:

Women with age ≥ 18 and ≤ 40
Indication of (neo) adjuvant chemotherapy
Prior chemotherapy treatment
Patients with menstrual periods in the last 6 months
In use of contraceptive methods
Without breast cancer recurrence
Capacity to read and understand the informed consent

Exclusion Criteria:

Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
Patients whom initiated chemotherapy treatment before entering the study
Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
Previous diagnosis of infertility

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

1

队列和干预

团体/队列
Pre menopausal women with breast cancer Pre menopausal women with breast cancer prior treatment in face of infertility evoked by chemotherapy

研究衡量的是什么？

主要结果指标

结果测量	大体时间
To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility 大体时间：Baseline and 1 year after after the first interview	Baseline and 1 year after after the first interview

次要结果测量

结果测量	大体时间
婚姻状况大体时间：基线	基线
Infertility risk for breast cancer patients after accepting chemotherapy 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Minimal percentage of cure necessary for patients accept the chemotherapy treatment 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Age when diagnosed 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Number of children 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Desire to have kids 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Scholarity 大体时间：Baseline	Baseline
Period of time since the diagnosis 大体时间：Baseline	Baseline
Chemotherapy scheme administration 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Period of time from the last menstruation period 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview
Description of quality of life of patients with the EORTC QLQ-BR23 大体时间：Baseline and 1 year after the first interview	Baseline and 1 year after the first interview

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Latin American Cooperative Oncology Group

合作者

Grupo de Estudios Clínicos Oncológicos Peruano

调查人员

研究主任：Gustavo Werutsky, MD、Latin American Cooperative Oncology Group

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):133-4.
Benson JR, Jatoi I, Keisch M, Esteva FJ, Makris A, Jordan VC. Early breast cancer. Lancet. 2009 Apr 25;373(9673):1463-79. doi: 10.1016/S0140-6736(09)60316-0.
Cardoso F, Loibl S, Pagani O, Graziottin A, Panizza P, Martincich L, Gentilini O, Peccatori F, Fourquet A, Delaloge S, Marotti L, Penault-Llorca F, Kotti-Kitromilidou AM, Rodger A, Harbeck N; European Society of Breast Cancer Specialists. The European Society of Breast Cancer Specialists recommendations for the management of young women with breast cancer. Eur J Cancer. 2012 Dec;48(18):3355-77. doi: 10.1016/j.ejca.2012.10.004. Epub 2012 Oct 29.
Colleoni M, Rotmensz N, Robertson C, Orlando L, Viale G, Renne G, Luini A, Veronesi P, Intra M, Orecchia R, Catalano G, Galimberti V, Nole F, Martinelli G, Goldhirsch A. Very young women (<35 years) with operable breast cancer: features of disease at presentation. Ann Oncol. 2002 Feb;13(2):273-9. doi: 10.1093/annonc/mdf039.
Vallejos Sologuren C, Gómez HL, et al. Clinicopathologic and outcome variables of worse prognosis in premenopausal patients (pts) age 35 and younger. 2010 Breast Cancer Symposium. Abstract 65
Reichman BS, Green KB. Breast cancer in young women: effect of chemotherapy on ovarian function, fertility, and birth defects. J Natl Cancer Inst Monogr. 1994;(16):125-9.
Senkus E, Gomez H, Dirix L, Jerusalem G, Murray E, Van Tienhoven G, Westenberg AH, Bottomley A, Rapion J, Bogaerts J, Di Leo A, Neskovic-Konstantinovic Z. Attitudes of young patients with breast cancer toward fertility loss related to adjuvant systemic therapies. EORTC study 10002 BIG 3-98. Psychooncology. 2014 Feb;23(2):173-82. doi: 10.1002/pon.3384. Epub 2013 Aug 29.
Gradishar WJ, Schilsky RL. Ovarian function following radiation and chemotherapy for cancer. Semin Oncol. 1989 Oct;16(5):425-36. No abstract available.
Stearns V, Schneider B, Henry NL, Hayes DF, Flockhart DA. Breast cancer treatment and ovarian failure: risk factors and emerging genetic determinants. Nat Rev Cancer. 2006 Nov;6(11):886-93. doi: 10.1038/nrc1992. Epub 2006 Oct 12.
Dnistrian AM, Schwartz MK, Fracchia AA, Kaufman RJ, Hakes TB, Currie VE. Endocrine consequences of CMF adjuvant therapy in premenopausal and postmenopausal breast cancer patients. Cancer. 1983 Mar 1;51(5):803-7. doi: 10.1002/1097-0142(19830301)51:53.0.co;2-v.
Moore HCF, et al. Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in earlystage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance). J Clin Oncol 32:5s, 2014 (suppl; abstr LBA505)
Brandberg Y, Michelson H, Nilsson B, Bolund C, Erikstein B, Hietanen P, Kaasa S, Nilsson J, Wiklund T, Wilking N, Bergh J; Scandinavian Breast Group Study 9401. Quality of life in women with breast cancer during the first year after random assignment to adjuvant treatment with marrow-supported high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin or tailored therapy with Fluorouracil, epirubicin, and cyclophosphamide: Scandinavian Breast Group Study 9401. J Clin Oncol. 2003 Oct 1;21(19):3659-64. doi: 10.1200/JCO.2003.07.020.

有用的网址

Ferlay J, Shin HR, Bray F, et al. GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC Cancer Base No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年5月1日

初级完成 (实际的)

2020年6月15日

研究完成 (实际的)

2020年6月15日

研究注册日期

首次提交

2016年1月27日

首先提交符合 QC 标准的

2016年8月8日

首次发布 (估计)

2016年8月11日

研究记录更新

最后更新发布 (实际的)

2020年10月5日

上次提交的符合 QC 标准的更新

2020年10月1日

最后验证