This trial is evaluating whether Active Monitoring will improve 1 primary outcome, 13 secondary outcomes, and 17 other outcomes in patients with Ductal Carcinoma in Situ. Measurement will happen over the course of Baseline.
This trial requires 1200 total participants across 2 different treatment groups
This trial involves 2 different treatments. Active Monitoring 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.
"CIS is a precancerous condition of the urethra, vulva and penis. The most common site is the penis, accounting for 70% of cases, followed by the urethra (20%) and the vulva (10%). The condition is often asymptomatic. Histologically, it is a metaplastic change of urothelial cells. The term is from the Latin terminology 'carcinomatous in situ' and means 'in situ carcinoma'. The neoplastic transformation takes place in either vulval or penile urothelium. The presence of the neoplastic change at the time of biopsy is essential to make a diagnosis." - Anonymous Online Contributor
"Recent findings emphasize the need for a detailed biopsy of suspicious lesions in order to identify CIS and provide staging and treatment information that would improve the long-term prognosis. Therefore, an important and routine biopsy is advocated for any lesions found on HSIL or HSIL+CIN, in particular for those with a high probability of invasive SCC requiring extensive surgical resection." - Anonymous Online Contributor
"The incidence of CCS, as reported by the SEER database, appears to be close to the overall incidence of invasive carcinoma in females. A substantial proportion, however, of these CCS appears not to have been detected by the usual means. We estimate that up to one in four invasive carcinomas detected in the United States could have been in situ at diagnosis." - Anonymous Online Contributor
"Although the incidence of carcinoma in situ in this population is low (0.07%) it is a well-known fact that all cases with precancerous changes (carcinoma in situ) cannot be cured. However, thanks to modern developments in cancer screening it is now possible to identify those women who are going to develop invasive cancer. Current research is currently focused on determining the risk and effectiveness of screening for carcinoma in situ in patients at risk for cervical intraepithelial neoplasia (CIN) type." - Anonymous Online Contributor
"Treatment of cervical carcinoma in situ are highly dependent on the characteristics of the individual. Larger, high grade lesions require more extensive surgical excision. Tissue margins and lymph nodes are not always affected by the treatment plan. It is unlikely that there is a treatment option for most patients with carcinoma in situ of the cervix." - Anonymous Online Contributor
"The cause of carcinoma in situ remains unclear. One explanation that is gaining traction is that it arises from a lesion of the epithelial basal layer which lacks adequate amounts of epithelial permeability due to loss of tight junctions. This lesion is a result of reduced cell proliferation, loss of cell layer cohesion and increased levels of cellular permeability. If the lesion occurs in the anogenital region, the cause could be related to the action of estrogen, which prevents the epithelial cell proliferation and induces further epithelial changes during puberty." - Anonymous Online Contributor
"Patients with carcinoma in situ are more difficult to manage than conventional epithelial carcinomas. However, they can be treated effectively using modern chemotherapeutic agents and radiation. Patients with carcinoma in situ should continue to receive these treatments because they are effective at prolonging survival." - Anonymous Online Contributor
"Carcinoma in situ that has not spread beyond the cervix and uterus does not affect survival. Treatment decisions are therefore not influenced by the location of the disease." - Anonymous Online Contributor
"Cancers treated with surgery and radiation therapy were most often treated using active monitoring. Only one or two treatments were received by patients who did not undergo active monitoring. Whether or not active monitoring is effective for preventing recurrence of cancers from which the patient had previously survived remains to be determined." - Anonymous Online Contributor
"In a recent study, findings show an increased rate of local recurrence of CIC. Early detection of CIC is therefore important. There is no evidence for a higher rate of CIS metastasis in the elderly." - Anonymous Online Contributor
"Although most women were satisfied after surgery and were generally satisfied with the outcome of the intervention, the majority of study participants were exposed to some risks associated with cancer follow-up and are likely to continue to be exposed to them throughout their survivorship. For many women, the most salient risk may be the psychological distress and burden associated with anxiety and distress related to the follow-up activities." - Anonymous Online Contributor
"Based on the results of this analysis of 1251 patients with CIS, the 2-year and 25-year survival rates appear to be excellent and have not significantly changed over time." - Anonymous Online Contributor