Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Erik van der Heijden, MD, PhD

EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute deformation of the node by the beating heart. Whether EBUS elastography may further increase the sensitivity to predict the presence or absence of malignancy is unclear.

We suggest to use EBUS elastography strain pattern analysis for this assessment and correlate these measurements with the final pathology outcome to determine NPV, PPV, sensitivity and specificity of this analysis to predict the presence or absence of malignancy in patients with (suspected) lung cancer in a prospectively obtained observational cohort study.

Patients will undergo a routine EBUS and/or EUS or EUSb with Pentax series EBUS or EUS scopes in combination with Hitachi Preirus Hi-Vision ultrasound processor with installed elastography software. Normal international guidelines for staging, diagnosis and specimen acquisition will be followed. For a normal evaluation B-mode measurements from all lymph node regions are obtained assessing size and standard ultrasound characteristics and all lymph nodes in the regions of interest that meet the criteria for fine needle aspiration will be sampled. For this study, in addition to the normal B-mode assessment of five sonographic B-mode characteristics elastography strain graph video, elastography image, and a strain histogram from the region of interest will be obtained.

Fine needle aspiration for cytology evaluation will be obtained from nodes based on imaging characteristics or standard sonography characteristics following current everyday clinical practice and the international guidelines. Subsequently, the patient charts will be retrospectively analysed after completion of the diagnostic and/or surgical treatment of the (suspected) lung cancer to match the obtained imaging data to pathology results (cytology and or histology where present) and clinical follow up until 6 months after the diagnostic procedure.

E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer

E-PREDICT Evaluating the Predictive Value of EBUS ELASTOGRAPHY STRAIN in Patients With (Suspected) Lung Cancer

stiffness/strain is a relative measure and has therefor no units

Radboud University Medical Center

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Premature Birth

Infertility

Polycystic Ovary Syndrome

Primary Ovarian Insufficiency

Menopause, Premature

Pregnancy Complications

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Menopause

All Drugs and Chemicals

Hormones

WING IU LI

PUI WAH JACQUELINE CHUNG

PUI WAH JACQUELINE CHUNG, MBBS

KAREN NG, MBBS

NGA PING PATRICIA IP, MBBS

This study aims to assess the association of Anti-Müllerian hormone (AMH) with polycystic ovarian syndrome, premature ovarian insufficiency and fertility. The main objectives include the following:

1. To study the level of serum AMH in women with PCOS and to evaluate the utility of serum AMH in the diagnosis of PCOS.
2. To evaluate the level of serum AMH in women with POI and to evaluate the utility of serum AMH in the management of POI.
3. To evaluate the associations of basal AMH level with FSH level and AFC respectively for women undergoing ART treatment.
4. To determine the optimal regimen of gonadotropin for ovarian stimulation for women undergoing ART treatment.
5. To evaluate the predictive value of serum AMH in reproductive outcomes including oocyte quality, embryo quality, pregnancy loss, clinical pregnancy and live birth rate in women undergoing ART treatment.

\[Background\] Anti-Müllerian hormone (AMH), which level can be assessed in serum, is a product of follicular granulosa cells of preantral and small antral follicles in the ovary. AMH expression increases prior to follicle-stimulating hormone (FSH)-dependent selection (follicles up to 8 mm) and rapidly decreases thereafter (follicles \> 8 mm. Thus, serum AMH level is a reliable marker of functional ovarian reserve as it reflects the pool of growing follicles. Since AMH is relatively cycle independent and has no inter-rater variability, it is considered to be a more reliable biomarker of ovarian function across an array of clinical conditions when compared with follicle-stimulating hormone (FSH) and antral follicular count (AFC).

\<Association between AMH and polycystic ovarian syndrome (PCOS)\> PCOS is a common endocrine disorder that causes menstrual irregularity and hyperandrogenism in women. It affects approximately 4-20% of women of reproductive age. Women with PCOS have been shown to have elevated AMH levels when compared with women without PCOS as there is an increased number of ovarian follicles in PCOS. Therefore, AMH is being increasingly recognised as a marker for the diagnosis of PCOS. However, a specific cutoff value is yet to be determined. When the issue is addressed, serum AMH levels could potentially replace ultrasound in the diagnosis of PCOS as ultrasound is more costly and less accessible.

\<Association between AMH and premature ovarian insufficiency (POI)\> POI is defined as the cessation of ovarian function before the age of 40 years. Timely diagnosis is important in order to appropriately counsel and treat the patients with POI.

Prompt initiation of hormone replacement therapy is vital to minimise the risk of long-term health complications including osteoporosis and premature cardiovascular disease. AMH levels were significantly low to undetectable in women with POI. Since AMH is independent of the timing in a menstrual cycle, the measurement may be beneficial in the phase of menstrual irregularity and could potentially help to assess the progression of ovarian senescence.

\<Associations between AMH and Fertility\> Serum AMH level is an important indicator of women's ovarian reserve and a crucial tool in assisted reproductive technology (ART) for the evaluation of women's fertility. A recent systematic review concluded that basal serum AMH is a strong pretreatment predictor of poor response to controlled ovarian stimulation (COS) and correlates with the risk of ovarian hyperstimulation syndrome. As such, clinicians can individualise the stimulation protocols to optimise the ovarian response. In addition, AMH-based prognostication counselling can be provided to patients with realistic expectation regarding the ART outcomes.

Ovarian reserve has a well-established positive correlation with pregnancy outcome. However, current evidence of AMH in the prediction of reproductive outcome following ART treatment remains controversial. Therefore, there is a need to study the predictive value of AMH on pregnancy outcome in women undergoing ART.

\[Hypothesis\]

1. Serum AMH level is elevated in women with PCOS.
2. Serum AMH level is very low or undetectable in women with POI.
3. Serum AMH level has a significant correlation with FSH and AFC in women undergoing ART treatment.
4. Serum AMH level can predict reproductive outcomes following ART treatment.

\[Study design\] This is a prospective observational study.

\[Methods\] Investigators will collect data from patients who undergo management for PCOS and POI in the Department of Obstetrics and Gynaecology at the Prince of Wales Hospital from 2022 to 2026. For patients undergoing investigation of PCOS and POI, routine venous blood tests for AMH and hormonal profile including FSH, luteinizing hormonal (LH), oestradiol (E2) levels will be obtained. For patients undergoing ART treatment, routine venous blood tests for AMH and hormonal profile, and transvaginal ultrasound for AFC will be arranged to assess the patients' ovarian reserve prior to the commencement of treatment. Patients will be recruited and consent will be obtained for the storage of any remaining serum from the blood tests. The stored blood samples will then be retrieved for this study.

\[Data processing and analysis\] Data analysis will be performed using the Statistical Packages of Social Sciences for Windows (SPSS, Inc). Data will be presented by percentage, mean and standard deviation, and median where appropriate. Comparisons between groups will be carried out by Student T test/Mann-Whitney U test for continuous variables and Chi-square/Fisher's exact test for categorical data. Two-tailed P\<0.05 will be considered significant.

\[Sample size\] All patients fulfilling the inclusion criteria attending the Department of Obstetrics and Gynaecology at the Prince of Wales Hospital from 2022 to 2026 will be recruited. The sociodemographic records of the participants including their menstrual history, routine hormonal results, ovarian reserve assessment and ultrasound assessment of AFC will be obtained. Metabolic screening results and ART treatment records and subsequent laboratory and reproductive outcome will be obtained if necessary.

Clinical Application of Serum Anti-Müllerian Hormone (AMH) Measurements

To evaluate the serum AMH level of women who undergo investigation for polycystic ovarian syndrome (PCOS), premature ovarian insufficiency (POI) or subfertility

To assess the type of gonadotropin used for ovarian stimulation for women undergoing ART treatment

To assess the total gonadotropin dose used for ovarian stimulation for women undergoing ART treatment

To evaluate the number of oocytes retrieved during oocyte retrieval for women undergoing ART treatment

To evaluate the serum FSH level of women who undergo ART treatment

To evaluate the serum LH level of women who undergo ART treatment

To evaluate the serum estradiol level of women who undergo ART treatment

To evaluate the AFC of women who undergo ART treatment

To assess for the presence of gestational sac using ultrasonography after embryo transfer procedure for women undergoing ART treatment

To assess whether live babies are born after women receive ART treatment

Study title	NCT ID	Conditions	Eligibility	Organization
E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer	NCT02488928	Lung Cancer	18 Years -	Radboud University Medical Center
E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer	NCT02488928	Lung Cancer	18 Years -	Radboud University Medical Center
Clinical Application of Serum Anti-Müllerian Hormone (AMH) Measurements	NCT05858307	Anti-Müllerian ... Polycystic Ovar... Premature Ovari... Fertility Issue...	10 Years - 44 Years	Chinese University of Hong Kong

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