Assessing Urinary Hormones in Female Cancer Survivors

NCT03197532 | Completed

• 1 other identifier: 811323
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Women of late to mid reproductive age may participate in a study using novel methodology to identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis, which may have important implications for reproduction and may signal reproductive senescence.

Conditions

Effects of Chemotherapy

Keywords

fertility; hormones; healthy; chemotherapy; oncofertility; alkylating agent; fertility after cancer; late effects; survivorship; healthy volunteers; perimenopause; middle age

Outcome Measures

Primary Outcomes (5)

• Urinary Follicle Stimulating Hormone (FSH)

  Integrated urinary follicular-phase Follicle Stimulating Hormone (FSH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.

  up to 49 days each menstrual cycle

• Urinary Luteinizing Hormone (LH)

  Integrated urinary follicular-phase Luteinizing Hormone (LH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.

  up to 49 days each menstrual cycle

• Urinary Estrone Conjugate (E1C)

  Estrone Conjugate (E1C) in urine samples collected daily for 2 menstrual cycles will be measured in ug/dL by means of E1C immunoassay.

  up to 49 days each menstrual cycle

• Urinary Pregnanediol-glucuronide

  Pregnanediol-glucuronide (PDG) in urine samples collected daily for 2 menstrual cycles will be measured in ug/mL by means of PDG immunoassay.

  up to 49 days each menstrual cycle

• Urinary Creatinine

  Urinary Creatinine in urine samples collected daily for 2 menstrual cycles will be measured in mg/mL by means of spectrophotometric assay.

  up to 49 days each menstrual cycle

Secondary Outcomes (1)

• Luteal and follicular phase lengths

  up to 49 days each menstrual cycle

Study Arms (3)

Group 1

Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.

Group 2

Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.

Group 3

Reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Regularly menstruating postmenarchal, mid-reproductive aged female cancer patients treated with high dose alkylating agent chemotherapy or with an alkylator score of 1 or more. * Unexposed, regularly menstruating mid-reproductive aged women, and unexposed, regularly menstruating late reproductive aged women.

You may qualify if:

• Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.
• Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.
• Healthy, late reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility.

You may not qualify if:

• Pregnancy or lactation within the previous 3 months
• Use of hormonal contraception or replacement within the previous 3 months
• Body Mass Index greater than 30 kg/m2
• Excessive exercise greater than 1 hour per day
• Any medical condition other than cancer known to be associated with premature ovarian failure (such as Turners Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushings syndrome, hyperprolactinemia, and polycystic ovary syndrome)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

daily urinary collections for 2 menstrual cycles

Study Officials

• Clarisa R Gracia, MD, MSCE

  University of Pennsylvania, Reproductive Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: June 23, 2017
• Study Start: January 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)