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AS703 - Association of sex steroid hormones and biliary tract cancers in men and women

AS703 - Association of sex steroid hormones and biliary tract cancers in men and women

[This page is intended to provide a study summary, the sections of which are below. Please complete these sections, as applicable. The headings below are suggested headings. You can remove inapplicable sections, or add new ones relevant to your study]

Investigator Names and Contact Information

Jill Koshiol (koshiolj@mail.nih.gov)

Introduction/Intent

Gallbladder cancer (GBC) has a female predominance with a worldwide female‐to‐male incidence rate ratio of 2:1, while incidence rates for other cancers of the biliary tract (e.g. extrahepatic bile duct cancer [EHBDC]) are higher in men. Previous research has demonstrated a positive association between female reproductive factors, such as parity and reproductive years, with GBC and an inverse relationship with EHBDC. However, no study has directly measured sex steroid hormones to evaluate their role in GBC and EHBDC in either men or women. We propose to leverage the Biliary Tract Cancers Pooling Project (BiTCaPP) to examine the role of pre-diagnostic circulating sex steroid hormones with the development of GBC and EHBDC in men aged ≥50 and postmenopausal women aged ≥50. Using a case-control design nested within BiTCaPP, we will select GBC and EHBDC cases matched 1:2 to controls. From the Women’s Health Initiative, we will select 171 participants (41 GBC cases matched to 82 controls and 16 EHBDC cases matched to 32 controls) from the observation study and clinical trial (HRT [placebo arm only], all DM or CaD) with 0.5 ml of serum or plasma available at baseline. Participants should not have reported gallstones, undergone a cholecystectomy, or be taking hormone replacement therapy at baseline.

Specific Aims:  

Aim 1. To examine the associations between sex-steroid hormones (estradiol, estrone, progesterone, testosterone, dehydroepiandrosterone [DHEA], androstenedione, dihydrotestosterone [DHT], and SHBG) levels and GBC in older men and postmenopausal women (≥50 years of age), separately.

We hypothesize that individuals with increased pre-diagnostic estrone, estradiol, progesterone levels will be associated with an elevated risk of GBC cancer in both postmenopausal women and older men. We further hypothesize that DHEA, DHT, androsterone, and testosterone will not be associated with increased with increased risk of GBC.

Aim 2. To examine the associations between sex-steroid hormones (estradiol, estrone, testosterone, DHEA, androstenedione, DHT, and SHBG) levels and EHBDC in older men and postmenopausal women (≥50 years of age), separately.

We hypothesize that individuals with increased pre-diagnostic estrone, estradiol, and progesterone levels will be associated with a decreased risk of EHBDC cancer in both postmenopausal women and older men. We further hypothesize that DHEA, DHT, androsterone, and testosterone will not be associated with increased with increased risk of EHBDC.