[Patient and Public Involvement in Cancer Clinical Research].

The involvement of patients and the public with researchers is essential in clinical research on cancer treatment. In recent years, patient and public involvement(PPI)has been required in all medical research processes. This paper summarizes practical considerations and examples of the PPI process referred to in the"Patient and Public Involvement(PPI)Guidebook"of the Japan Agency for Medical Research and Development(AMED).

[Clinical research and conflict of interest].

In clinical research, the term "conflict of interest" appears quiet frequently. Conflict of interest does not always result in research misconduct, nor is it always an issue. Conflict of interest rules differ depending on the type and stage of research, and researchers are expected to choose and follow them appropriately.

Public Attitudes toward COVID-19 Vaccinations before Dawn in Japan: Ethics and Future Perspectives.

Unlabelled: Improving public understanding and acceptance are critical for promoting coronavirus (COVID-19) vaccination. However, how to promote COVID-19 vaccine programs remains controversial due to various ethical issues. This study, thus, aimed to survey the acceptance of COVID-19 vaccines among Japanese citizens and discuss relevant ethical issues.

[Two Cases of Carcinoma en Cuirasse, as Cutaneous Metastasis of Breast Cancer].

We present 2 cases of carcinoma en cuirasse, an uncommon clinical manifestation of metastatic cutaneous breast cancer. Case 1, a 70-year-old woman, presented with diffuse erythematous, indurated skin lesions that covered her entire anterior chest wall. Skin biopsy revealed tumor cells in the dermis which were ER and PgR positive and HER2 negative.

Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies' Activities in Japan.

Objective: The objective of this study is to assess public attitudes toward pharmaceutical companies' secondary uses of patient records and public preferences regarding consent approaches.

Method: 3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of "clinical trials"; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents.

Comparative Assessment of Non-trial Access to Investigational Medical Products in the U.S. and Japan.

The U.S. and Japan have preapproval access systems for patients who have exhausted approved treatment options.

Ethical and professional challenges encountered by Japanese healthcare professionals who provide genetic counseling services.

It is important to identify ethical and professional challenges associated with genetic counseling services and systems to improve these services. In previous studies, specific challenges in genetic counseling were categorized into 16 domains. However, these studies were limited to a few countries, and genetic counseling differs according to national cultures or systems.

Public Attitudes Toward the Secondary Uses of Patient Records for Pharmaceutical Companies' Activities in Japan.

Objective: The objective of this study is to assess public attitudes toward pharmaceutical companies' secondary uses of patient records and public preferences regarding consent approaches.

Method: 3000 responses to an online survey were collected from adults in Japan. The questionnaire included 32 items related to (1) awareness of "clinical trials"; (2) awareness of the processes of drug development, such as cost, time, and the number of candidate substances in a new drug; (3) knowledge of the laws and regulations for use of patient records in Japan; (4) assessment of the public benefit of the secondary use of patient records; (5) preferences for consent for the secondary use of patient records; and (6) basic characteristics of the respondents.

Where Can Patients Obtain Information on the Preapproval Access Pathway to Investigational Treatment in Japan? A Survey of Patient Advocacy Organizations' Websites.

Investigational treatments are those that have been approved for testing in humans but are not yet available as an approved treatment option. For many patients with a terminal illness who have no approved treatment option and are not eligible for a clinical trial, investigational treatments are the last resort. However, not much is known about the dissemination of information by patient advocacy organizations (PAOs).

Lateral thoracoaxillar dermal-fat flap for breast conserving surgery: the changes of the indication and long-term results.

Background: Oncoplastic breast conserving surgery had been challenged to achieve both of local control and the cosmetic appearance of preserved breast. We developed the lateral thoracoaxillar dermal-fat flap (LTDF) as an oncoplastic procedure to fill the defect of breast-conserving surgery in 1999.

Methods: A total of 2338 breast cancer patients underwent surgery from January, 2000 to December, 2017.

"Tell me what you suggest, and let's do that, doctor": Patient deliberation time during informal decision-making in clinical trials.

Informed consent is an essential part of an ethical clinical trial; to this end, researchers have developed several interventions to promote participants' full understanding of trials and thereby improve the consent process. However, few empirical studies have examined how patients make the decision of whether to give consent. The objective of this study, therefore, is to analyze patients' decision-making process when participating in clinical trials.

Fat necrosis after breast-conserving oncoplastic surgery.

Background: Fat necrosis is a subjective early as well as delayed complication, which sometimes mimics local recurrence and ruins the quality of life by pain and poor cosmetic result. While, the frequency and severity of fat necrosis are important issues that breast surgeons should explain to the patient, these data are not revealed well.

Methods: A total of 1476 patients who underwent breast surgery from January 2000 to December 2012 were enrolled in the present study.

Periaortitis induced by epirubicin and cyclophosphamide for a patient with advanced breast cancer.

Aortitis is an extremely rare condition, and it may mimic febrile neutropenia during cancer chemotherapy. A 55-year-old female diagnosed with T2N1M1 stage IV breast carcinoma received chemotherapy with EC (epirubicin 90 mg/m and cyclophosphamide 600 mg/m every 3 weeks). At the eleventh day after the first administration of EC, she developed a high-grade fever of 38 °C and stomatitis.

Pseudomyxoma peritonei due to low-grade appendiceal mucinous neoplasm with symptoms of inguinal hernia and uterine prolapse: a case report and review of the literature.

Pseudomyxoma peritonei (PMP) is an unusual condition in which massive amounts of mucinous ascites in conjunction with mucinous peritoneal and omental implants occur. We herein report a case of PMP due to low-grade appendiceal neoplasm (LAMN) and a literature review to clarify the clinical features of PMP. A 68-year-old female suffered from anorexia and abdominal distension and was referred to the emergency department of our hospital.

Specific sites of metastases in invasive lobular carcinoma: a retrospective cohort study of metastatic breast cancer.

Background: Invasive lobular carcinoma (ILC) is known to be the second most common histological type following invasive ductal carcinoma (IDC). Definitive clinical features of ILC are controversial.

Methods: We retrospectively analyzed a cohort of 330 patients with metastatic breast cancer, 303 of IDC, 19 of ILC, and 8 of others.

Rapid Changes in Circulating Tumor DNA in Serially Sampled Plasma During Treatment of Breast Cancer: A Case Report.

BACKGROUND The analysis of circulating tumor DNA (ctDNA) is expected to be a modality to determine the status of cancer in real time. This case indicated utilities and issues in measuring the ctDNA in cancer patients. CASE REPORT A 45-year-old woman with metastatic breast cancer was treated with bevacizumab and paclitaxel.

Biliary cancer developed after the reparative surgery for congenital choledochal cyst: a case report and review of the literature.

The incidence of bile duct cancer developed in the patients with congenital choledochal cysts (CC) with a history of reparative surgery is not well known. We experienced a case developed choleductal cancer 45 years after reparative surgery. She underwent reparative surgery with cyst excision and hepatic bile duct duodenal anastomosis at 1 year of age.

Report of a case with gallbladder carcinoma: P53 expression of the peritumor epithelium might predict biliary tract recurrence.

Introduction: The over-expression of P53 protein in gallbladder carcinoma is a biomarker correlating with a poor survival. However, the significance of P53 expression in peritumor tissues is unknown. We experienced a case of gallbladder carcinoma where the operative specimen showed over-expression of P53 on the peritumor epithelium, and early recurrence developed at the biliary tract.

Pseudo-Meigs' syndrome due to ovarian metastases from colon cancer: a case report and review of the literature.

We herein experienced a case with pseudo-Meigs' syndrome that developed both synchronous and metachronous metastases to the ovary from ascending colon cancer. A 57-year-old female visited a hospital for a 2-month history of abdominal distension and voiding difficulty. Massive pleural effusion on the right side and a small amount of left-sided pleural effusion were detected on CT.

A study of tumor heterogeneity in a case with breast cancer.

Tumor heterogeneity has been suggested based on clinical and pathological findings. Several clinical findings can be explained by tumor evolution during progression and metastasis. We herein report a case of metastatic breast cancer indicated tumor heterogeneity by clinical findings and a genomic analysis.

Report of a case with a spontaneous mesenteric hematoma that ruptured into the small intestine.

Introduction: A spontaneous mesenteric hematoma is a rare condition. Furthermore, it is extremely rare that the mesenteric hematoma caused gastrointestinal bleeding with an unknown etiology. We experienced a case with a spontaneous mesenteric hematoma that ruptured into the jejunum.

Report of a case with T1a gallbladder poorly differentiated adenocarcinoma, solid type, which developed into lymph node metastases.

We experienced a case with gallbladder carcinoma growing limited to the mucosa (T1a), which developed massive lymphatic vessel spread and lymph node metastases.A 72-year-old man was referred to our hospital for the swelling of his gallbladder during a routine ultrasound sonography checkup. We diagnosed the patient with gallbladder carcinoma with lymph node metastasis according to the radiographic findings and performed the open cholecystectomy and lymph node dissection.