3-D Printed Models of cervix developed to train doctors in cervical cancer screening and treatment

The researchers from Rice University

Many resource-poor settings are not able to provide cervical cancer screening, diagnosis, and treatment of women population because of lack of training. A team of students from Rice University has designed a 3-D Printed Models of the cervix that can help the healthcare providers to train them to carry out screening and provide treatment for cervical cancer.

This will be specifically used for training doctors and nurses in developing countries and low-resource areas in the U.S.

Cervical cancer kills nearly 300,000 women every year and more than 80% deaths are reported in developing countries. In about 90% of patients, the cervical cancer is preventable.

Rice students Christine Luk, Elizabeth Stone and Rachel Lambert are senior design students enrolled in the course Global Health Design. Together with graduate student Sonia Parra, they developed a low-cost, interactive training model that mimics a woman’s pelvic region and can be used to practice different cervical cancer screening and treatment procedures.

The simple device includes different models of cervix showing evolving stages of cervical cancer from entirely normal to pre-cancerous to definitive cancer.  The models fit into holder placed at the back of the device.

The training doctor or nurse can have real-life experience of what it looks like at the doctor’s office after the speculum is inserted and the cervix is visualized. The models can easily be switched around to simulate different conditions of the cervix and they also respond to the application of hot water just as a gynecologist applies acetic acid in clinical settings.

In addition to the training aspect, the device also is handy in teaching the doctors and nurses about how to proceed with abnormal results of the screening tests or a lesion is seen during the examination.

Some cervical models are made of a ballistic gel, that allows the doctors to practice colposcopy, cervical biopsy; cryotherapy, and loop electrosurgical excision procedure at low costs.

“Here in the states we have the ability to perform Pap smears and other practices, but in other countries where this model is used, such as Mozambique and El Salvador, they may not have the necessary infrastructure to do so,” Christine Luk said. “That’s why it’s important that this model can train as many procedures as possible.”

The students have already tested the device in training clinics in El Salvador and the Rio Grande Valley in Texas. Each training session is modified to fit the specific needs of an area.

The team from Rice is trying to collaborate with manufacturers to mass produce the device for areas in need so newly trained medical providers can train others.

Rice News Release

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Here is a video about how the device works

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Could modified PapTest help detect endometrial and ovarian malignancy?

A new multiplex PCR-based test called PapSEEK was able to detect endometrial and ovarian malignancy from fluid samples collected during routine Pap test, reported Yuxuan Wang, MD, of Johns Hopkins University School of Medicine in Baltimore.

The authors also used a longer sampling brush that sweeps cells from the lining of the uterus called Tao brush, to further increase the sensitivity of detection for the less accessible tumors.

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News from SGO annual meeting: Cervical cancer screening should not be stopped at age 65

One in every 5 women diagnosed with cervical cancer is above the age of 65 years in the USA, which suggests a reconsideration of current cervical cancer screening guidelines which advice to stop the screening at the age 65 years for women who are at low risk and have received adequate screening in the past.

The data was presented by the lead researcher Sarah Dilley, MD, MPH, a fellow in gynecologic oncology at The University of Alabama at Birmingham at the Society of Gynecologic Oncology’s 2018 Annual Meeting on Women’s Cancer.

The current recommendations by American Cancer Society, American Society for Clinical Pathology and American Society of Colposcopy and Cervical Pathology advice that cervical screening should stop after women turn 65 years of age if they have had adequate screening and are at low risk. The guidelines do not address the risk stratification for cervical cancer in women over the age of 65. 

The researchers analyzed the 2014-15 data Surveillance, Epidemiology and End Results (SEER-18) program database which showed that 19.7 percent of cervical cancer cases were diagnosed in women age 65 or older.

Analysis of the National Cancer Database for the year 2014-15 showed that 18.9% of cervical cancer were diagnosed in women who were who were 65 years or older.

Risk stratification by ethnicity showed that in 22.9 percent of African American women were age 65 or older, compared to 20.5 percent of non-Hispanic white women at the time of diagnosis of cervical cancer.

When the incidence was analyzed by age, only 5.1 percent of cervical cancer cases were diagnosed from age 20 to 29, while 8 percent were diagnosed from age 70 to 79.

Dr. Dilley said in a news release, “This data point contradicts the misperception that women usually only are diagnosed with cervical cancer at a younger age.”

“Our data suggest that a considerable proportion of women are diagnosed with cervical cancer after age 65, which suggests that patients are being aged out too soon or not getting screened at all,” Dr. Dilley continued. “Professional societies should consider extending the age screening requirements to improve outcomes for this older population of women.”

The results of this study suggest that the decision to stop cervical cancer screening should only be taken after an informed shared decision-making between patient and her doctor and some women over the age of 65 years may still benefit from screening to prevent age-based disparities in cervical cancer diagnoses.

News Release 

Media courtesy: LA times and JAMA

Could modified PapTest help detect endometrial and ovarian malignancy?

A new multiplex PCR-based test called PapSEEK was able to detect endometrial and ovarian malignancy from fluid samples collected during routine Pap test, reported Yuxuan Wang, MD, of Johns Hopkins University School of Medicine in Baltimore.

The authors also used a longer sampling brush that sweeps cells from the lining of the uterus called Tao brush, to further increase the sensitivity of detection for the less accessible tumors.

The paper was published in Journal Science Translational Medicine on March 21, 2018, and the study identified endometrial cancer with high sensitivity from samples collected by Pap test and Tao brush, while sensitivity for reporting ovarian cancer was low, but increased when it was combined with DNA testing in the blood samples.

Pap test has been instrumental in bringing down the incidence of cervical cancer by about 60% since its introduction in 1940 but it is not able to detect endometrial and cervical cancers. The researchers at John Hopkins University based this test on the evidence put forth by the previous study published in Journal Science Translational Medicine that both endometrial cancer and ovarian cancer shed cells that collect at the cervix. These cells can be identified by looking for ‘Tumor DNA’ in the samples.

It is to be noted that DNA mutations have already been identified for specific cancers. In the study, the researchers tested for 18 genes common to endometrial and cervical cancer.

The researchers looked at 1915 samples from 1658 individuals, including 656 patients with endometrial or ovarian cancers and 1002 healthy controls.

PapSEEK was used on Pap test samples of 382 women with endometrial cancer, 245 women with ovarian cancer, and 714 women without cancer.

PapSEEK gave a positive result in 81% of endometrial cancer patients, which included 78% of patients with stage I or stage II disease, and 92% of patients with stage III or stage IV disease.

While 33% of Pap test samples were PapSEEK-positive in ovarian cancer patients, including 34% of patients with stage I or stage II disease and 33% of patients with stage III or stage IV disease.

When samples collected by Tao brush was examined, they tested positive in 93% of cases endometrial cancer and 45% cases of ovarian cancer.

The researchers then tested plasma samples from 83 ovarian cancer patients and found that 43% of these patients had detectable circulating tumor DNA. On applying the papSEEK test to the Pap test samples from this group, it was seen that positive results were obtained in 63% of patients.

Currently, there are no screening tests for both endometrial and ovarian cancer and incidence of both is on the rise.  

More than 63,000 women are diagnosed with endometrial cancer in the U.S. each year, and more than 11,000 die each year from the disease. Ovarian cancer is less common but more lethal, affecting more than 22,000 women and killing about 14,000 in the U.S. each year.

Yuxuan Wang, first author on the study said, “Our study demonstrates the ability to detect endometrial and ovarian cancer using cervical fluids obtained using two different methods.”

Full text

Media Courtesy: John Hopkins University 

USPSTF simplifies cervical cancer screening recommendations: Dual testing no longer advised

The US Preventive Services Task Force (USPSTF) has issued new draft recommendations for cervical cancer screening with a major change that it recommends either cervical cytology (CC) or high-risk HPV (hrHPV) test as a screening procedure every 3 years for women aged 30-65 years, and not both ( Grade A)  

It still continues to recommend Pap screening every 3 years for women aged 21- 29 years in line with 2012 recommendations (Grade A).

Screening is not recommended in women younger than 21 years because despite their being sexually active, screening in this population subgroup does not reduce cervical cancer incidence or mortality (Grade D).

It also continues to recommend against routine screening for women aged 65 and above who had regularly undergone screening earlier and are not at high risk for cervical cancer and in women who have had a total hysterectomy with no history of cervical intraepithelial neoplasia [CIN] grade 2/3 or cervical cancer (Grade D).

These recommendations do not apply to women with in utero exposure to diethylstilbestrol, or a compromised immune system (living with HIV).

“Cervical cancer is highly curable when found and treated early,” says USPSTF member Carol Mangione, MD, MSPH. “Most cases of cervical cancer occur in women who have not been regularly screened or treated. Therefore, making sure all women are adequately screened and treated is critical to reducing deaths from cervical cancer.”

“The Task Force looked at the evidence on the effectiveness of different screening tests and intervals based on age, and found that after age 30, the Pap test and hrHPV tests are both effective for cervical cancer screening,” says Task Force member Maureen G. Phipps, MD, MPH. “Women ages 30 to 65, therefore, have a choice between the Pap test every three years or hrHPV test every five years.”

The Task Force’s draft recommendation statement and draft evidence review have been posted for public comment on the Task Force website. It is open for public comments from September 12 through October 9, 2017.

 The American Cancer Society (ACS), American Academy of Family Physicians (AAFP), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP) recommends similar screening strategy for women aged 21-29 years. 

They defer with USPSTF for age group 30-65 years of age in whom dual screening with cytology and HPV testing is advised every 5 years or cytology alone every 3 years.

ACOG also prefers cotesting with cytology and HPV testing every 5 years but  only cytology every 3 years is acceptable according to a 2016 statement.

USPSTF Draft Recommendation Statement Full Text 

HPV testing vs Pap test in cancer screening: Cochrane Systematic review

A negative HPV test is more reassuring than a negative Pap test, as the cytology screening has a higher chance of being false negative thereby missing some women with precancerous lesions and delaying treatment says the result of a Cochrane Systematic review published ahead of print.

Since decades the usual method of screening for cervical cancer is based on cell cytology, but since the etiological relationship between cervical cancer and HPV infection was confirmed along with advent of HPV testing in 1999, the supremacy of these two tests is debated.

Some physician advice Pap and HPV both, especially for women over 30 years old, who are most at risk of cervical cancer, getting both tests provides the best assurance of finding cervical disease before it becomes cancer.

Younger women (20-30) are advised to get HPV test only if their Pap smear looks "inconclusive" or "borderline.”

This systematic review by Cochrane was aimed at determining efficacy of the two tests in detecting precancerous lesions (CIN 2+ and CIN 3+). Literature search for relevant studies till November 2015 identified about 40 studies amounting to a total of 140,000 women between 20 to 70 years old who underwent cervical cancer screening.

Data analysis identified true positives (TP), false positives (FP), true negatives (TN), and false negatives for each screening test (HPV test and cytology) used in each study.

It was seen that HPV test was more sensitive than conventional Pap test and liquid based test in identifying CIN 2+ and CIN 3+, but less specific than Pap test in detecting precancerous lesion.

Data analysis showed that for every 1000 women screened, around 20 women will have precancerous lesions. If HPV test is used, it will correctly identify 16 of the 20 women to be positive for the lesions (but will miss 4 women who have the lesions). The Pap test will correctly identify 12 of the 20 women (but will miss 8 women).

Similarly, for every 1000 women screened, there will be 980 women who will not have precancerous changes. The HPV test will correctly identify 879 women as disease free (but 101 women will be incorrectly told that they have a lesion). The Pap test will correctly identify 951 women (but 29 will be incorrectly told that they have a lesion).

This high false positive rate of HPV testing will lead to high unnecessary referrals and further tests like colposcopy, biopsy and surgery but at the same time it will also identify 50% more women with precancerous changes as compared to conventional cytology.  

The authors concluded that,” Whilst HPV tests are less likely to miss cases of CIN 2+ and CIN 3+, these tests do lead to more unnecessary referrals. However, a negative HPV test is more reassuring than a negative cytological test, as the cytological test has a greater chance of being falsely negative, which could lead to delays in receiving the appropriate treatment.”

Source: Koliopoulos G, Nyaga VN, Santesso N, Bryant A, Martin-Hirsch PP, Mustafa RA, Schünemann H, Paraskevaidis E, Arbyn M. Cytology versus HPV testing for cervical cancer screening in the general population. Cochrane Database Syst Rev. 2017;8:CD008587. doi: 10.1002/14651858.CD008587.pub2. PMID: 28796882

Access the abstract here.