Method for diagnosing selected adenocarcinomas

Abstract

A method for the early diagnosing of selected adenocarcinomas in a human comprising the steps of removing a bodily sample from the human, and assaying the bodily sample for elevated expression of a specific gene. The gene being assayed for in the bodily sample is the TGFB-4 gene (hereinafter referred to as the endometrial bleeding associated factor (ebaf) gene. The bodily sample can be tissue from a specific organ in the body, or a blood sample. Increased levels of ebaf in the sample relative to basal levels may be indicative of a mucinous adenocarcinoma of the colon or ovaries, or an adenocarcinoma of the testis.

Description

CROSS REFERENCE[0001] This application claims the benefit of U.S. Provisional Application Ser. No. 60 / 025,800, entitled "Method for the Early diagnosis of Colon Cancer, Abnormal Uterine Bleeding, or Pregnancy", filed Aug. 27, 1996.[0003] A method for diagnosis of human bodily conditions, and more particularly, a method for diagnosing selected mucinous adenocarcinoma of the colon, or ovaries, or an adenocarcinoma of the testis.BACKGROUND OF INVENTION[0004] Early diagnosis of particular pathological conditions of the human body can provide patients with adequate time to make well informed decisions regarding the treatment of their pathological condition, as well as prepare for the potential incapacitation of the patient. One such pathological condition is colon cancer. The American Chemical Society has reported that colon cancer is the second most common cause of cancer in the United States (Fleischer, D. et al. Detection and Survival of Colorectal Cancer (1989) JAM 261 (4) :580. It h...

AI Technical Summary

Benefits of technology

[0022] Applicants have also discovered that, due to alternative splicing during the transcription of the gene into mRNA, three different mRNA transcripts can result from the transcription of the ebaf gene. One of the transcripts is 1.5 kb in size, one is 2.1 kb, and the remaining is 2.5 kb. Consequently, such processing will produce three isoforms upon translation of the transcripts. Regardless, elevated expression of the ebaf gene can be determined from elevated levels of any transcript or any isoform. Hence, one object of the present invention is to provide an accurate, reliable method for the diagnosis and detection of an adenocarcinoma of the testis, or a mucinous adenocarcinoma of the colon in a human male.

[0023] Another object of the present invention is to provide an accurate, reliable method for the diagnosis and detection of mucinous adenocarcinoma of the ovaries, or a mucinous adenocarcinoma of the colon in a human female.

Problems solved by technology

In addition, there are other factors which could result in a false positive result for this test.

For example, it has been found that aspirin and other non-inflammatory analgesics have been known to cause irritation in the stomach and increased gastro-intestinal tract blood loss, thereby producing in a false positive result.

The patient's ingestion of rare beef and fruits and vegetables which contain catalases and peroxidases within 24 hours of administering the test may also cause a false positive result.

However, soon after this test became available to health professionals, it was observed that this test was simply too insensitive to recognize numerous types of colon cancers.

Even in this role though, it has met with only limited success.

However, researchers have also acknowledged that this screening method contains inherent limitations.

Moreover, general patient discomfort while undergoing this screening is believed to be one of the obstacles in providing mass screening for the general population.

Finally, health professionals acknowledge that there is a very slight risk of perforating a patient's colon while undergoing the procedure.

However, there is only a 20 to 25% chance of living after diagnosis, if the diagnosis is made after the disease has spread beyond the ovary.

Presently, there are methods available to diagnose ovarian cancer, but such methods have inherent limitations.

However, endometriosis, pelvic inflammatory disease of the tubes and ovaries, uterine fibroids, and pregnancy can also elevate levels of CA 125 in the blood, resulting in false positives.

However, like the pelvic examination, this method provides no definitive answer regarding the presence of cancer in the ovaries.

However, such a procedure presents a problem to the patient in that it could contaminate the scrotum, which could then be a site for the development of cancer.

Moreover such a biopsy could disturb the pattern of nodal metastases, and make points for subsequent surgery difficult to predict.

However this procedure has limitations in that it is done surgically, like the biopsy, and is a qualitative inspection of the testes.

Consequently, a false positive or false negative can result from this procedure.

However, this method contains inherent limitations in that it has been determined that low testosterone states, and marijuana use by the patient can produce false positives.

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