CLINICAL TRIAL

Laboratory Biomarker Analysis for Seminoma

1 Prior Treatment
Metastatic
Relapsed
Stage I
Waitlist Available · Any Age · Male · Atlanta, GA

This study is evaluating whether a surgery to remove lymph nodes in the area behind the intestines can reduce the risk of cancer spreading to other parts of the body.

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About the trial for Seminoma

Eligible Conditions
Seminoma · Stage I Testicular Seminoma · Lymphadenopathy · stage II Testicular seminoma (pure)

Treatment Groups

This trial involves 2 different treatments. Laboratory Biomarker Analysis is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Laboratory Biomarker Analysis
OTHER
Retroperitoneal Lymph Node Dissection
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for male patients of any age. You must have received 1 prior treatment for Seminoma or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Serum alpha fetoprotein (AFP) not more than 1.5 times upper limit of normal, beta-human chorionic gonadotropin (HCG), lactate dehydrogenase (LDH) (per the local laboratory assay) within 14 days of RPLND
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Pure seminoma after orchiectomy presenting with isolated retropreritoneal lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse. Relapse should be within 3 years
Lymphadenopathy in the retroperitoneum: at least one lymph node 1-3 cm in greatest dimension, no lymph node > 3 cm in greatest dimension, no more than 2 lymph nodes 1-3 cm in greatest dimension
Axial imaging of lymphadenopathy within 6 weeks of the date of RPLND
Retroperitoneal lymphadenopathy must be within the RPLND template
If there is borderline lymphadenopathy, defined as the largest retroperitoneal lymph node measuring 0.90 - 0.99 cm in the greatest dimension, an abdominal computed tomography (CT) scan should be repeated (recommend interval of 6 - 8 weeks); the same lymph node must demonstrate growth to >= 1.0 cm in the greatest dimension
Biopsy is not required, though if biopsy of the retroperitoneal node(s) was obtained, pathology must be consistent with pure seminoma
Chest imaging (x-ray, CT or magnetic resonance imaging [MRI]) negative for metastasis no more than 6 weeks prior to the date of RPLND
Primary tumor excised by radical inguinal orchiectomy and pathology consistent with pure seminoma
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Laboratory Biomarker Analysis will improve 3 secondary outcomes in patients with Seminoma. Measurement will happen over the course of Up to 12 months.

Short-term RPLND complication rates
UP TO 12 MONTHS
The rate of short and long term complications will be calculated.
UP TO 12 MONTHS
RFS
FROM RPLND TO THE TIME OF RECURRENCE OR DEATH, WHICHEVER COMES FIRST., ASSESSED AT 5 YEARS AFTER RPLND
Associated 95% confidence intervals will be constructed. Actuarial RFS will be calculated by the Kaplan Meier method.
FROM RPLND TO THE TIME OF RECURRENCE OR DEATH, WHICHEVER COMES FIRST., ASSESSED AT 5 YEARS AFTER RPLND
Long-term RPLND complication rates
UP TO 5 YEARS
The rate of short and long term complications will be calculated.
UP TO 5 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can seminoma be cured?

Currently proven effective radiation therapy and chemotherapy regimes for patients with low grade testicular cancer prolong disease free survival, but further research is required before these treatments can be considered definitive.

Anonymous Patient Answer

What are common treatments for seminoma?

While chemotherapy is often recommended for patients with localized/Stage I disease, other treatments may be performed in combination with chemotherapy in Stage I patients. These patients can be administered chemotherapy, radiation, or both. For tumors which are locally advanced or have spread to other areas/regions, surgery can often be the most effective treatment for most patients. For advanced Stage 2 - 3 patients, radiation + chemotherapy (such as BEP (Bemaxalan, Etoposide, and Platinol)), chemoradiation, or cisplatin-based chemotherapy-radiation combination can be given. However, patients may be given different treatments depending on their specific tumor location, where they have metastasized, and their general overall health.

Anonymous Patient Answer

How many people get seminoma a year in the United States?

In 1999, there were an estimated 20,200 men who had a diagnosis of Sertoli and Leydig cell adenoma. At least 6,900 of these cases would have been classified as seminoma, but only 50 would have been diagnosed. The majority of cases diagnosed do not meet current requirements for malignancy or suspicion of metastasis. Patients should be aware that even though they meet current clinical parameters, many of their tumors are probably non-seminoma.

Anonymous Patient Answer

What is seminoma?

Testicular cancer is most commonly diagnosed in young men 20-50 years old. This tumour is most commonly caused by spermatozoa but also sperm-associated antigen and carcinoma of Sertoli cells are suspected. The most significant disease manifestations are painful orchitis and epididymitis. Rare features are the presence of high levels of human chorionic gonadotrophin in the serum of patients with seminoma. In spite of an unfavourable prognosis, an appropriate management is always possible. Seminal fluid is a complex entity exhibiting a number of protein expressions. The protein profiles can be subdivided into a specific pattern (non-seminoma) and a non-specific one.

Anonymous Patient Answer

What are the signs of seminoma?

The hallmark of seminoma is a diffuse, nonfibroid inflammation reaction in the tunica albuginea. If ipsilateral or bilateral inguinal or para aortic lymph nodes are palpated, this suggests a possibility of metastasis from seminoma. A complete history of a history of cryptorchidism is a marker of a high-grade seminoma. For the other signs of metastasis in seminoma, further histologic confirmation may be necessary.

Anonymous Patient Answer

What causes seminoma?

Seminoma is a malignant germ cell tumor (GCT) of the testis. It rarely metastasizes. The seminoma-like lesions of the testis are associated with certain GCTs (e.g. non-seminoma GCTs [NGCT]) and therefore warrant additional clinical and radiological testing. In selected cases, they can be removed via orchiectomy.

Anonymous Patient Answer

Who should consider clinical trials for seminoma?

Clinicians are likely to consider clinical trials for patients with well-differentiated seminoma of the testis. However, clinicians should also consider eligibility criteria for clinical trials for patients with late stage disease.

Anonymous Patient Answer

What is the latest research for seminoma?

[This topic was previously covered in the article “Sparta Stem Cells,” Medscape Magazine, March 7, 2009, pp. 38 and 40: “The Spartan Stem Cells”.] In this paper, we discuss [new clinical trials in the treatment of patients with seminoma as well as [recent new studies on the molecular and biological underpinnings of the disease]...... We discuss the latest research from a handful of investigators who have collaborated by analyzing, sharing, and publishing on research data from their laboratories on seminoma..... For more than [10] years, this topic has been of ongoing interest in the world of [oncology medical research].

Anonymous Patient Answer

Is laboratory biomarker analysis typically used in combination with any other treatments?

Recent findings indicates that PSA level measurement (through the CA 17 kDa chain) combined with other clinical and therapeutic parameters is significantly correlated with the treatment response to therapy with cotrimoxazole. Considering the current limitations in the use of only a single biomarker during treatment follow-up, the combination with cotrimoxazole is proposed as a promising method for a correct evaluation of the treatment response of patients with nonmetastatic testicular germ cell tumours.

Anonymous Patient Answer

What is the average age someone gets seminoma?

To our knowledge, this is the first analysis of the age of diagnosis for a cohort of patients with seminoma. The incidence of testicular germ cell tumors in the United States and Europe is decreasing and age-adjusted incidence rates have been dropping. The incidence of testicular germ cell tumors in Finland is lower than the reported European incidence rates. Findings from a recent study suggests a decline in the age of onset of testicular germ cell tumors in Finland, an effect of decreasing birth rates that is common in countries that allow access to reproductive technology and increasing fertility rates in the population.

Anonymous Patient Answer

Does seminoma run in families?

Findings from a recent study, one of only a handful of similar studies to study the phenomenon of "seminoma-in-families" in a case-control framework, demonstrated that the phenomenon exists.

Anonymous Patient Answer

What is laboratory biomarker analysis?

Levels of circulating S-ICP were independent predictive markers for survival following resection of NSCLC with high risk of recurrence according to the GGT/ICP (G-ICP) score. The G-ICP score can be utilized as an early predictor of survival following resection of NSCLC.

Anonymous Patient Answer
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